MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Model Number 5531-G-713

Device Problem Difficult to Insert (1316)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

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 relevant reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

Mr used a triathlon insert on tuesday, that wouldn¿t sit properly despite repeated attempts to insert it; a duplicate was opened that sat properly immediately.

Manufacturer Narrative

An event regarding seating/locking issues involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device noted the following: device had notable damage consistent with attempted implantation.No other remarkable observations were noted.Material analysis of the returned device noted the following: material analysis is not performed as this is not related to material integrity.Damage consistent with attempted implantation.-medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: material analysis of the returned device noted the following: material analysis is not performed as this is not related to material integrity.Damage 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

Mr used a triathlon insert on tuesday, that wouldn¿t sit properly despite repeated attempts to insert it; a duplicate was opened that sat properly immediately.

• Brand Name: X3 TRIATHLON CS INSERT #7 13MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9764843
• MDR Text Key: 185497326
• Report Number: 0002249697-2020-00411
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046014
• UDI-Public: 07613327046014
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 5531-G-713
• Device Catalogue Number: 5531G713
• Device Lot Number: LFD472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other