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-511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 13-jul-2007 with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding wear.Lot id - there have been no other similar events for the reported lot.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.
Event or Problem Description
A revision knee procedure was required following a triathlon cr primary knee implanted in (b)(6) 2008.When the revision took place the x3 poly insert was seen to have delaminated on the medial side and showed signs of wear on posterior lateral side as well.
Event or Problem Description
A revision knee procedure was required following a triathlon cr primary knee implanted in (b)(6) 2008.When the revision took place the x3 poly insert was seen to have delaminated on the medial side and showed signs of wear on posterior lateral side as well.
Additional Manufacturer Narrative
Reported event: an event regarding revision due to wear involving a triathlon insert was reported.The event was confirmed through visual inspection of the photograph provided.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted triathlon insert component with gross damage/wear evident on the bearing surface.There appeared to have been delamination evident on the medial side and wear on posterior lateral edge.Medical records received and evaluation: no medical records were provided for review.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: an event regarding revision due to wear involving a triathlon insert was reported.The event was confirmed through visual inspection of the photograph provided.The photographs show a recently explanted triathlon insert component with gross damage/wear evident on the bearing surface.There appeared to have been delamination evident on the medial side and wear on posterior lateral edge.It is noted that the device was in-situ for more than 10 years.The exact cause of the event could not be determined because insufficient information was provided.Additional information including need revision operative report and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, 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: 8150865
• Report Number: 0002249697-2018-03973
• Device Sequence Number: 252436
• Product Code: MBH
• UDI-Device Identifier: 07613327050547
• UDI-Public: 07613327050547
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 07/31/2012
• Device Catalogue Number: 5530-G-511
• Device Lot Number: 1NLMLD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR