Brand Name | S-ROM CUP ACE,A2 L32,51DP |
Type of Device | TOTAL HIP PROSTHESIS |
Baseline Brand Name | S-ROM CUP ACE, A2 L32, 51DP |
Baseline Generic Name | PROSTHESIS ACETABULAR CUP |
Baseline Catalogue Number | 553751 |
Baseline Device Family | S-ROM TOTAL HIP |
Baseline Device 510(K) Number | K844050 |
Baseline Device PMA Number | |
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 12/06/1985 |
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 Key | 322671 |
MDR Report Key | 333297 |
Event Key | 313690 |
Report Number | 1818910-2001-00172 |
Device Sequence Number | 1 |
Product Code | LPH |
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 Received | 05/18/2001 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 553751 |
Device LOT Number | S014711 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 04/18/2001 |
Device Age | unknown |
Event Location |
Other
|
Date Manufacturer Received | 04/18/2001 |
Was Device Evaluated By Manufacturer? |
No
|
Date Device Manufactured | 05/01/1993 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
|
|