MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5537-G-313

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The rim connected to the insert was completely separated and the same size was replaced again.

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.

• Brand Name: NO 3 TRIATH TS PLUS TIB INS X3 POLY 13MM
• Type of Device: 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; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18986189
• MDR Text Key: 338710738
• Report Number: 0002249697-2024-00505
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327027143
• UDI-Public: 07613327027143
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5537-G-313
• Device Lot Number: PL582H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female