MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5530-G-311
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding joint instability and poly damage/wear involving a triathlon insert was reported.The instability event was not confirmed, however the damage to the insert was confirmed based on the photograph of the device provided.Method & results: device evaluation and results: no product was returned for evaluation however one photograph was provided.The photograph shows a recently explanted insert with blood on the surface.There is damage/wear on the posterior aspect of the bearing surface on one compartment only.The locking wire is detached from the insert.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: no product was returned for evaluation however one photograph was provided.The photograph shows a recently explanted insert with blood on the surface.There is damage/wear on the posterior aspect of the bearing surface on one compartment only.The locking wire is detached from the insert.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including device evaluation, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that patient's right knee was revised due to instability.Intra-operatively, the poly was found to be noticeably damaged on the right side most posterior aspect of the device.Patient's 11 mm cr insert was revised to a 16 mm insert.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8086733
• Report Number: 0002249697-2018-03758
• Device Sequence Number: 16204093
• Product Code: MBH
• UDI-Device Identifier: 07613327050448
• UDI-Public: 07613327050448
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: 5530-G-311
• Device Lot Number: MLDDT1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/19/2018
• 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: Hospitalization; Required Intervention