MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5551-G-320
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/29/2013
Type of Reportable Event	Serious Injury
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "mechanical failure of right total knee arthroplasty".
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "mechanical failure of right total knee arthroplasty" as per medical review, ".Under a diagnosis of instability, right knee revision surgery was undertaken on (b)(6) 2013.The instability was confirmed and a bearing exchange from 9-mm cr to 13-mm cs performed while retaining all other devices because well fixed and positioned.".
Additional Manufacturer Narrative
An event regarding instability involving a triathlon patella was reported.Conclusions: it was reported that the patient's right knee was revised due to mechanical failure.The liner was revised.Based on the information provided there is no indication or allegation that device reported in this investigation may have contributed to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8716836
• Report Number: 0002249697-2019-02317
• Device Sequence Number: 1756804
• Product Code: MBH
• UDI-Device Identifier: 07613327014815
• UDI-Public: 07613327014815
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 5551-G-320
• Device Catalogue Number: 5551-G-320
• Device Lot Number: 00R8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 05/06/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR