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

Model Number	5532-P-509
Medical Device Problem Codes	Fitting Problem (2183); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate that devices were manufacture and accepted into final stock on with no reported discrepancies.
Event or Problem Description
During a total knee replacement, just finished inserting the new femoral and tibial components.The surgeon then engaged the new tibial bearing insert into place, which ended up not seating down all the way on one side (medial).After thorough inspection, the decision was made by the surgeon to removed and exchanged with another tibial bearing insert.
Additional Manufacturer Narrative
An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.
Event or Problem Description
During a total knee replacement, just finished inserting the new femoral and tibial components.The surgeon then engaged the new tibial bearing insert into place, which ended up not seating down all the way on one side(medial).After thorough inspection, the decision was made by the surgeon to removed and exchanged with another tibial bearing insert.

• Brand Name: TRIATHLON #5 PS INSERT 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
• MDR Report Key: 6484454
• Report Number: 0002249697-2017-01218
• Device Sequence Number: 13752819
• Product Code: MBH
• UDI-Device Identifier: 07613327042818
• UDI-Public: (01)07613327042818(11)160413(17)210430(10)LEZ640
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: 04/30/2021
• Device Model Number: 5532-P-509
• Device Catalogue Number: 5532P509
• Device Lot Number: LEZ640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: Other
• Patient Age: 71 YR