MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5510F501
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening involving a triathlon femoral component was reported.The event was confirmed through clinician review of the medical record provided.Malposition of the femoral component was also confirmed through the provided medical records.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: femoral component malposition with an oblique joint line persisting after a previous revision surgery for baseplate malposition contributed to a persisting overload condition in the arthroplasty resulting in femoral component loosening requiring another revision surgery to solve all problems in the arthroplasty.Product history review: indicated 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.Conclusion: a review of the provided medical records by a clinical consultant indicated: femoral component malposition with an oblique joint line persisting after a previous revision surgery for baseplate malposition contributed to a persisting overload condition in the arthroplasty resulting in femoral component loosening requiring another revision surgery to solve all problems in the arthroplasty.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
It was reported that patient's left knee was revised after patient complaint of pain.Surgeon originally believed the tibial baseplate was loose.According to the operative note supplied by the rep, the baseplate was found not to be loose, but the femoral component was suspected to be loose.The femoral component (implanted 2016) and insert (implanted 2017) were revised to a ps femoral component and a ts insert.Rep provided implant sheets and operative reports for all surgeries and pre-revision x-rays and reported that no further information is available due to hospital policy.On 27aug2018 update as per medical review received: femoral component malposition.

• Brand Name: TRIATHLON CR FEM COMP #5 L-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7887362
• Report Number: 0002249697-2018-02946
• Device Sequence Number: 1939843
• Product Code: JWH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 10/31/2020
• Device Catalogue Number: 5510F501
• Device Lot Number: ANA8P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: 58 YR
• Patient Weight: 80