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-211

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.

Event Description

Insert size is different.There should be an 11mm product when opened, but there was an estimated 9mm product.

Manufacturer Narrative

An event regarding size/fit issue involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: the insert was received without its locking wire.Scratch marks and damage can be observed on the surface of an insert.Damage observed on the insert consistent with attempted implantation.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: it was reported that the insert size appears different.The event was not confirmed.The device was returned for evaluation.The insert was received without its locking wire.Scratch marks and damage can be observed on the surface of an insert.Damage observed on the insert consistent with attempted implantation.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Insert size is different.There should be an 11mm product when opened, but there was an estimated 9mm product.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15152757
• MDR Text Key: 299001136
• Report Number: 0002249697-2022-01134
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046212
• UDI-Public: 07613327046212
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 5532-G-211
• Device Catalogue Number: 5532-G-211
• Device Lot Number: 5X7VLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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