Surgeon was unable to assemble the acumatch a-series polyethylene liner into the already implanted acetabular shell component. The surgeon elected to remove the a-series component and implant a competitor's device. The surgery continued without incident.

The device involved in this incident was evaluated and the dimensional parameters proved to be within specifications. Visual examination of the polymer liner showed damage to the locking mechanism consistent with misalignment during impaction. Add'l a-series liner assembly problems have been identified through exactech's complaint handling system. All the device eval performed response to these assembly complaints also indicated that the problems originated from the surgeon's failure to properly align the two components before impaction. An internal corrective action (ca2000-14) is underway to enhance the a-series system to that the alignment process is more forgiving in the operating theatre. The following report was refused delivery on 9/12/00 at cdrh. It was addressed to: medwatch reporting, cdrh hfz-531 room 340k, 1350 piccard dr. , rockville, md 20850. Reference: fedex tracking # 4570 5458 9487. Co called to confirm the address after the refusal and was told not to include "room 340k" on the address. Previously co had been told by the medwatch office that the room number was required. Co consulted with the contractor office and was told to use p. O. Box 3002 and leave off the street address and room number. Because of the conflicting info given to the co regarding the medwatch mailing address, co has decided to fax the report for co. Co apologizes for the later delivery of this notificatiion but co just received the report back from fedex courier yesterday. Co would very much appreciate calling the co to confirm receipt of this report.