MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5532-G-311-E

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

During surgery, when surgeon asked to open the implant.Dr noticed that the wire was not fixed at one side of insert.Triathlon x3 tibial bearing insert -ps size 3/11.

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.

Manufacturer Narrative

Reported event: an event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: no product was returned for evaluation however, photographs were provided for review.The photographs show an insert with the locking wire removed.From the photographs the insert appears unremarkable however scratches are visible on the locking wire consistent with attempted implantation of the device.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no product was returned for evaluation however, photographs were provided for review.The photographs show an insert with the locking wire removed.From the photographs the insert appears unremarkable however scratches are visible on the locking wire consistent with attempted implantation of the device.The event could not be determined because insufficient information was provided.Further information such as return of the device, and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

During surgery, when surgeon asked to open the implant.Dr noticed that the wire was not fixed at one side of insert.Triathlon x3 tibial bearing insert -ps size 3/11.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 15435471
• MDR Text Key: 300588468
• Report Number: 0002249697-2022-01355
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327338188
• UDI-Public: 07613327338188
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5532-G-311-E
• Device Catalogue Number: 5532-G-311-E
• Device Lot Number: 453EEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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