MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ6 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5512-F-602

Device Problem Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra-operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.

Manufacturer Narrative

An event regarding loosening involving triathlon femoral component was reported.The reported loosening was not confirmed.Method & results: device evaluation and results: the femoral component was returned for evaluation with augments and stem attached.On the inferior surface there is evidence of bone cement with bone in-growth on the condyle section.The device has evidence of markings and scratches consistent with the explantation process.The device otherwise appears unremarkable for a device that was implanted since 2012.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted 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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

-+it was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra-operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.

• Brand Name: TRI TS FEMUR SZ6 RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9566593
• MDR Text Key: 185739577
• Report Number: 0002249697-2020-00052
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327026658
• UDI-Public: 07613327026658
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 5512-F-602
• Device Catalogue Number: 5512-F-602
• Device Lot Number: DXSZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 113