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-513
Medical Device Problem Codes	Material Erosion (1214); Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
Event or Problem Description
Knee revision due to poly wear.
Event or Problem Description
Knee revision due to poly wear.Update: additional comment provided by clinician: "review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posterial slope.To more accurately determine alignment, full length x-rays would be required.".
Additional Manufacturer Narrative
An event regarding wear involving a triathlon insert was reported.The event was confirmed based on evaluation of the returned device.Method & results product evaluation and results: material analysis concluded: the damage present on the posterior portion of the medial condyle was consistent with delamination.The damage present on the posterior portion of the lateral condyle was consistent with contact against the tibial baseplate.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "review of x-rays reveal the tibial component is in 5 degrees in varus and 5 degrees in posterial slope.To more accurately determine alignment, full length x-rays would be required." 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: the wear and delamination of the insert was confirmed based on the evaluation of the returned device.The exact cause of the event could not be determined because insufficient information was provided.Review of provided medical records reveal the tibial component is in 5 degrees in varus and 5 degrees in posterial slope which may have contributed to the wear of the device, however, the malposition cannot be confirmed as to more accurately determine alignment, full length x-rays would be required.No further investigation for this event is possible at this time.If additional information becomes available such as full length x-rays to indicate further evaluation is warranted, this record will be reopened.

• 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: 8975671
• Report Number: 0002249697-2019-03142
• Device Sequence Number: 18909770
• Product Code: MBH
• UDI-Device Identifier: 07613327050554
• UDI-Public: 07613327050554
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 12/31/2017
• Device Catalogue Number: 5530-G-513
• Device Lot Number: MLTJ3P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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: 46 YR
• Patient Weight: 86