MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ3 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5512-F-301
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
As reported: "loose femoral component.No other information is available per hospital policy." a left femoral component, augments, and 16x100 stem were revised.
Event or Problem Description
As reported: "loose femoral component.No other information is available per hospital policy." a left femoral component, augments, and 16x100 stem were revised.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remained implanted.Clinical review: a review of the provided medical records by a clinical consultant stated the following comment: undated x-rays ap and lat.Left knee, labelled off films "2018": cemented, long stem modular revision tka reduced, nominal position.Undated implant invoice: triathlon cemented revision components.No clinical or pmh, no operative reports, no dated serial x-rays, no examination of explanted components.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for the case.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 event was not confirmed for loosening.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device return , clinical and past medical history, post op x- rays and examination of explanted components are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: TRI TS FEMUR SZ3 LEFT
• 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: 11300663
• Report Number: 0002249697-2021-00237
• Device Sequence Number: 4997401
• Product Code: MBH
• UDI-Device Identifier: 07613327026627
• UDI-Public: 07613327026627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 11/30/2019
• Device Model Number: 5512-F-301
• Device Catalogue Number: 5512-F-301
• Device Lot Number: KPEF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/10/2021
• 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 Weight: 77