MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM BEAD PA SZE5 BP; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5526B500
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision due to loosening/lack of fixation and instability involving a triathlon baseplate was reported.The instability event was confirmed based on the clinician review.X-rays were not provided, therefore the loosening/lack of fixation was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient- related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.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: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.X-rays and return of the device are needed to further investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not available.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "left knee, failed total knee arthroplasty." update to event description based on clinician review of the medical records provided: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.

• Brand Name: TRIATHLON PRIM BEAD PA SZE5 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: 9151362
• Report Number: 0002249697-2019-03365
• Device Sequence Number: 16905691
• Product Code: MBH
• UDI-Device Identifier: 07613327041378
• UDI-Public: 07613327041378
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: 03/31/2016
• Device Catalogue Number: 5526B500
• Device Lot Number: S3K9X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/03/2019
• 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: 63 YR