MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G613
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384); Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Poly insert didn't lock correctly in baseplate.They used another insert which locked into the baseplate with no issues.They did not need to exchange the baseplate.
Additional Manufacturer Narrative
Reported event: an event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed by visual inspection.Method and results: -device evaluation and results: the insert and the locking wire were returned for evaluation.The locking wire had been removed from the insert.The wire has several scratches and is bent which is indicative of contact with the baseplate during attempting to implant the insert.There is also damage observed on the posterior edges of the bearing surface in both compartments of the device.This type of damage is indicative of an obstruction on the posterior aspect of the insert which may have been the reason that the user failed to position the insert correctly on the baseplate.The locking wire groove of the anterior face of the device is damaged most likely due to explantation damage.-medical records received and evaluation: not performed as the reported component was not implanted.-device history review: dhr review for the reported lot was satisfactory.-complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: based on the visual inspection of the returned component, the observed damage on the posterior aspect of the insert is indicative of an obstruction during attempted seating of the insert onto the baseplate.The observed damage on the anterior face is indicative of attempted assembly of the insert onto the baseplate and subsequent removal of same.
Event or Problem Description
Poly insert didn't lock correctly in baseplate.They used another insert which locked into the baseplate with no issues.They did not need to exchange the baseplate.

• Brand Name: X3 TRIATHLON CS INSERT #6 13MM
• 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: 6444746
• Report Number: 0002249697-2017-01075
• Device Sequence Number: 13671731
• Product Code: MBH
• UDI-Device Identifier: 07613327045949
• UDI-Public: (01)07613327045949(10)161206(17)211231(10)LFL267
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 12/31/2021
• Device Catalogue Number: 5531G613
• Device Lot Number: LFL267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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: 70 YR
• Patient Weight: 120