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

Model Number	5532-G-713
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	05/12/2020
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.
Event or Problem Description
It was reported that the patient's right knee was revised due to liner wear and joint laxity.A 7 x 13 ps insert was revised to a 7 x 16 insert.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving triathlon insert was reported.The event was confirmed by the provided photographs.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted triathlon insert.The device was worn out.Explantation damage was also observed.Clinician review: no medical records were received for review with a clinical consultant.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: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted triathlon insert.The insert was worn out.Explantation damage was also observed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and the return of the device are needed to fully investigate the event.If further information becomes available or the product is returned to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to liner wear and joint laxity.A 7x13 ps insert was revised to a 7x16 insert.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 10122482
• Report Number: 0002249697-2020-01027
• Device Sequence Number: 2851206
• Product Code: MBH
• UDI-Device Identifier: 07613327046328
• UDI-Public: 07613327046328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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: 04/30/2014
• Device Model Number: 5532-G-713
• Device Catalogue Number: 5532-G-713
• Device Lot Number: LBL992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: 82 YR