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-613
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/04/2019
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 following devices were also listed in this report: triathlon p/a ps beaded #5l; cat # 5516f501; lot # ahs9s.Titanium bplate triathlon s6; cat # 5536b600; lot # ctd7479.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Index and revision.Postoperative diagnosis: the patient underwent left total knee arthroplasty (b)(6) 2015.Patient had mechanical complication with loose patella polyethylene implant, the patellar component was removed and the liner was exchanged (b)(6) 2018.Reported as cors per 5171 knee.Patient underwent left total knee revision for pji with all components exchanged in (b)(6) 2019.

• 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: 10044791
• Report Number: 0002249697-2020-00896
• Device Sequence Number: 19766019
• Product Code: MBH
• UDI-Device Identifier: 07613327050868
• UDI-Public: 07613327050868
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: 04/30/2023
• Device Model Number: 5532-G-613
• Device Catalogue Number: 5532-G-613
• Device Lot Number: 82208317C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/11/2020
• 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: 53 YR
• Patient Weight: 111