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	Degraded (1153); Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding instability due to baseplate malposition involving a triathlon baseplate was reported.The event was confirmed by medical review.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: baseplate malposition in excessive posterior tibial slope of 10° has contributed to flexion instability of the knee arthroplasty causing the femoral component to ride over the posterior tibial bearing border with consequent polyethylene wear with pain requiring revision surgery.High activity level may be considered a secondary factor to increase the adverse effects of instability.No device-related factors are associated with any of the implanted devices.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 investigation concluded that baseplate malposition in excessive posterior tibial slope of 10° has contributed to flexion instability of the knee arthroplasty causing the femoral component to ride over the posterior tibial bearing border with consequent polyethylene wear with pain requiring revision surgery.High activity level may be considered a secondary factor to increase the adverse effects of instability.No device-related factors are associated with any of the implanted devices.Because optimal component position is the responsibility of the surgeon, root cause of failure is procedure-related factors.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
Poly wear on triathlon knee need knee revision.Update based on the medical review, qs 21 may 2019: "relevant clinical history and time lines" [.] "clinical examination and x-rays were reported as ¿normal¿ but a diagnostic arthroscopy of the left knee documented wear in both the medial and lateral posterior segments of the bearing.Moderate instability was shown during arthroscopy." [.] "conclusion of assessment: baseplate malposition in excessive posterior tibial slope of 10° has contributed to flexion instability of the knee arthroplasty causing the femoral component to ride over the posterior tibial bearing border with consequent polyethylene wear with pain requiring revision surgery." [.].

• 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: 8699398
• Report Number: 0002249697-2019-02258
• Device Sequence Number: 11413143
• Product Code: MBH
• UDI-Device Identifier: 07613327041378
• UDI-Public: 07613327041378
• 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: 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): 06/14/2019

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: 05/31/2015
• Device Catalogue Number: 5526B500
• Device Lot Number: STA4N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: 65 YR
• Patient Weight: 83