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

Device Problems Fitting Problem (2183); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2017

Event Type  malfunction  

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 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.

Manufacturer Narrative

An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.

Event 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
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6484454
• MDR Text Key: 72502291
• Report Number: 0002249697-2017-01218
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327042818
• UDI-Public: (01)07613327042818(11)160413(17)210430(10)LEZ640
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: 06/16/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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: 71 YR