MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ2 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5512-F-201
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Device not returned.
Event or Problem Description
Subject presented with pain and her evaluation was consistent with loosening of her femoral component.Left knee revision.
Event or Problem Description
Subject presented with pain and her evaluation was consistent with loosening of her femoral component.Left knee revision.
Additional Manufacturer Narrative
Notification of a revision due to loosening has been reported twice, fda ref 0002249697-2022-01638 and fda ref 0002249697-2020-02446.Since the same failure for the same device has been reported twice, fda ref 0002249697-2022-01638 will be cancelled as a duplicate and the final report will be submitted under fda ref 0002249697-2020-02446.

• Brand Name: TRI TS FEMUR SZ2 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15803534
• Report Number: 0002249697-2022-01638
• Device Sequence Number: 5623283
• Product Code: MBH
• UDI-Device Identifier: 07613327026139
• UDI-Public: 07613327026139
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 10/31/2022
• Device Model Number: 5512-F-201
• Device Catalogue Number: 5512-F-201
• Device Lot Number: A7O9B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American