MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-P-509
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the "wire from insert locking mechanism appeared out of its place".
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

• Brand Name: TRIATHLON CS INS SIZE 5 9MM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15009525
• Report Number: 0002249697-2022-01008
• Device Sequence Number: 6819768
• Product Code: MBH
• UDI-Device Identifier: 07613327042306
• UDI-Public: 07613327042306
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2026
• Device Model Number: 5531-P-509
• Device Catalogue Number: 5531P509
• Device Lot Number: LKX136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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: Other
• Patient Sex: Unknown