MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-11-52E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr commented that on post op x-ray the mdm liner didn¿t look seated in trident cup although at time of operation it was solid & appeared to be solid.
Event or Problem Description
Dr commented that on post op x-ray the mdm liner didn¿t look seated in trident cup although at time of operation it was solid & appeared to be solid.
Additional Manufacturer Narrative
Reported event: an event regarding seating/ locking issue involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated that - x-ray provided does not confirm event, need additional information; primary operative report, clinical and past medical history and additional serial dated x-rays.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that doctor commented on post op x-ray that - mdm liner didn¿t look seated in trident cup although at time of operation it was solid and appeared to be solid.The event is not confirmed.A review of the provided medical records by a clinical consultant stated that - x-ray provided does not confirm event, need additional information; primary operative report, clinical and past medical history and additional serial dated x-rays.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and photographs/video depicting the gap observed are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9351227
• Report Number: 0002249697-2019-03832
• Device Sequence Number: 2734562
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 70623504
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR