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

Catalog Number	5530-G-313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The following was reported " during surgery the doctor put the insert on the tibia plate.He used the insert hammer twice however insert did not fit plate.He used the hammer again and the wire of insert was broken.Thus he used another insert and fitted the plate.After washing, he examined the possibility of wire pieces by sight and there was not any pieces.".
Event or Problem Description
The following was reported " during surgery the doctor put the insert on the tibia plate.He used the insert hammer twice however insert did not fit plate.He used the hammer again and the wire of insert was broken.Thus he used another insert and fitted the plate.After washing, he examined the possibility of wire pieces by sight and there was not any pieces.".
Additional Manufacturer Narrative
Reported event: an event regarding an assembly issue and crack/fracture involving a triathlon insert was reported.Crack/fracture was confirmed through analysis of the returned device.The assembly issue was not confirmed as the device was returned damaged.Method & results: -device evaluation and results: visual inspection.Visual inspection was performed as part of the material evaluation and indicated the following comments: implantation damage observed on the implant near the locking wire channel, no material or manufacturing defects were observed.Dimensional & functional inspection: not performed as the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis.Material evaluation was completed and indicated the following comments: implantation damage observed on the implant near the locking wire channel, no material or manufacturing defects were observed.-clinician review: no medical records were received for review with a clinical consultant.-device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: 8619686
• Report Number: 0002249697-2019-01975
• Device Sequence Number: 2087281
• Product Code: MBH
• UDI-Device Identifier: 07613327050455
• UDI-Public: 07613327050455
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 04/30/2023
• Device Catalogue Number: 5530-G-313
• Device Lot Number: DE38H5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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