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

Catalog Number	5530-G-211
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs provided are poor quality.The insert component appears to be recently explanted.There appears to be yellowing of the poly.It is not possible to determine if there is visible wear evident from the photographs provided.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 event regarding insert wear was not confirmed and the exact cause of the event could not be determined because insufficient information was provided.Additional information including device evaluation, operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
It was reported that the patient's knee was revised after patient complaint of pain and clicking.Intra-operatively, the poly part of the patellar component was found to have a portion broken off and all of the poly disassociated from the metal part of the patellar component.The 2x11 cr insert was also revised after wear was noted.The patient was revised to an all poly patellar component and a new insert of the same catalog number.Rep provided an intra-op picture and explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON CR 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: 9075126
• Report Number: 0002249697-2019-03217
• Device Sequence Number: 2503064
• Product Code: MBH
• UDI-Device Identifier: 07613327045444
• UDI-Public: 07613327045444
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 04/30/2015
• Device Catalogue Number: 5530-G-211
• Device Lot Number: LBV954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/17/2019
• 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: 69 YR