MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-500
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.A size 5 tritanium tibial component, size 5cr femoral component, and insert were revised to a size 5 universal baseplate, size 5ps femoral component, and insert.Surgeon's opinion was that the tibial component was implanted with too much varus.There are no allegations against the insert.Femoral component was revised to increase knee rotation, but otherwise there are no allegations against the femoral component.
Additional Manufacturer Narrative
An event regarding malposition involving a triathlon baseplate was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection: visual inspection of the explanted pictures indicates blood and biological matter but nothing remarkable to note.Ma - material analysis is not performed as this is not related to material integrity.Damage consistent with explantation.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.-clinician review:no medical records were received for review with a clinical consultant.   -product 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 lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.A size 5 tritanium tibial component, size 5cr femoral component, and insert were revised to a size 5 universal baseplate, size 5ps femoral component, and insert.Surgeon's opinion was that the tibial component was implanted with too much varus.There are no allegations against the insert.Femoral component was revised to increase knee rotation, but otherwise there are no allegations against the femoral component.

• Brand Name: TRITANIUM BPLATE TRIATHLON S5
• 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: 11730570
• Report Number: 0002249697-2021-00738
• Device Sequence Number: 19660347
• Product Code: MBH
• UDI-Device Identifier: 07613327041507
• UDI-Public: 07613327041507
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 03/31/2025
• Device Model Number: 5536-B-500
• Device Catalogue Number: 5536B500
• Device Lot Number: CTD45703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: 54 YR
• Patient Weight: 100