FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. S-ROM CUP ACE,A2 L32,51DP TOTAL HIP PROSTHESIS   back to search results
Catalog Number 553751
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 04/18/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Patient phoned with the complaint that they have had two revisions since 1990. Date of primary implant: 1990; acetabular cup revised in 1995; liner revised in 1997. Patient has acetabulum profundi; motorcycle accident caused need for surgery.

 
Manufacturer Narrative

H. 3 - selected as prosthesis remains implanted at this time. Revision surgery to be scheduled. Evaluation was not possible as the products were not returned. Review of the device history records found no problems. The investigation could not verify or identify the cause of the reported events. Based on company's investigation, the need for corrective action is not indicated. Should the product and/or additional information be received, the investigation will be reopened.

 
Manufacturer Narrative

H. 4. Received the mfr date from the mfr.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameS-ROM CUP ACE,A2 L32,51DP
Type of DeviceTOTAL HIP PROSTHESIS
Baseline Brand NameS-ROM CUP ACE, A2 L32, 51DP
Baseline Generic NamePROSTHESIS ACETABULAR CUP
Baseline Catalogue Number553751
Baseline Device FamilyS-ROM TOTAL HIP
Baseline Device 510(K) NumberK844050
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/06/1985
Manufacturer (Section F)
DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
325 paramount dr.
raynham MA 02767 0350
Manufacturer (Section D)
DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
325 paramount dr.
raynham MA 02767 0350
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
hans kusserow, mgr
700 orthopaedic drive
warsaw , IN 46581-0988
(219) 372 -7416
Device Event Key322671
MDR Report Key333297
Event Key313690
Report Number1818910-2001-00172
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/18/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number553751
Device LOT NumberS014711
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/18/2001
Device Ageunknown
Event Location Other
Date Manufacturer Received04/18/2001
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/1993
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH