MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE4 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5526-B-400
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2019
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
Knee revision due to instability.
Event or Problem Description
Knee revision due to instability.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving an triathlon baseplate was reported.The event was confirmed medical review.Method & results: -device evaluation and results: visual inspection - visual inspection was performed as part of the material analysis report (mar), dated which indicated that - biological material was observed on the porous coating of the femoral and tibial components.Damage on the articulating surface of the femoral component was consistent with articulation against the tibial component.Damage on the proximal surface of the tibial component was consistent with articulation against the femoral component.The chemistry of the femoral and tibial components were evaluated with x-ray fluorescence spectroscopy (xrf).Ma - damage consistent with articulation was observed on the femoral and tibial components.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Functional and dimensional inspection not performed as device was received in damage condition.-clinician review: : a review of the provided x-rays by a clinical consultant rejected and stated that : no clinical or pmh, no examination of explanted components.Based upon the information available for review, confirmation of instability of the left tka is noted on x-ray, but no determination can be made regarding the cause of this clinical event." -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: it was reported that patient knee was revised due to instability.The event was confirmed by medical review.Visual inspection was performed as part of the material analysis report (mar), dated which indicated that - biological material was observed on the porous coating of the femoral and tibial components.Damage on the articulating surface of the femoral component was consistent with articulation against the tibial component.Damage on the proximal surface of the tibial component was consistent with articulation against the femoral component.The chemistry of the femoral and tibial components were evaluated with x-ray fluorescence spectroscopy (xrf).Ma - damage consistent with articulation was observed on the femoral and tibial components.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided x-rays by a clinical consultant rejected and stated that : no clinical or pmh, no examination of explanted components.Based upon the information available for review, confirmation of instability of the left tka is noted on x-ray, but no determination can be made regarding the cause of this clinical event." the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON PRIM BEAD PA SZE4 BP
• 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: 9688349
• Report Number: 0002249697-2020-00244
• Device Sequence Number: 19746331
• Product Code: MBH
• UDI-Device Identifier: 07613327041354
• UDI-Public: 07613327041354
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 10/31/2018
• Device Model Number: 5526-B-400
• Device Catalogue Number: 5526B400
• Device Lot Number: EEJPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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
• Patient Weight: 70