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

Model Number	5530-G-611
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
Knee revision due to instability.
Event or Problem Description
Knee revision due to instability.
Additional Manufacturer Narrative
Reported event: an event regarding instability and wear involving a triathlon insert was reported.Instability was not confirmed, however, analysis of the returned device confirmed wear of the liner.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.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 observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the device was returned damaged.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Clinician review: a review of the provided medical records by a clinical consultant indicated: narrative: there was little medical information and some translational issues.The patient appears to have had a tka on the right for medial compartment disease, although the x-rays were not labeled.Over a period of 12 years the polyethylene wore and may have fractured.The patient was described as having no instability, so the indications for the surgery outside of the xray changes were not conveyed.A revision procedure was performed with poly exchange and patellar resurfacing.Intraoperatively a stable construct was accomplished.No follow-up data were provided.Conclusion/assessment: revision knee arthroplasty with poly exchange and patellar resurfacing for ¿patella problems¿ and poly wear/fracture.Event confirmation: the event of a revision can be confirmed.Root cause: the root cause of the revision was polyethylene wear and potential fracture and reported patella problems.The root cause of the poly wear/fracture cannot be ascertained.Product history review: review of the device history records indicate the 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 lot referenced.Conclusions: as per the clinician review; revision knee arthroplasty with poly exchange and patellar resurfacing for ¿patella problems¿ and poly wear/fracture.Event confirmation: the event of a revision can be confirmed.Root cause: the root cause of the revision was polyethylene wear and potential fracture and reported patella problems.The root cause of the poly wear/fracture cannot be ascertained.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, dated pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15785312
• Report Number: 0002249697-2022-01610
• Device Sequence Number: 3038369
• Product Code: MBH
• UDI-Device Identifier: 07613327050592
• UDI-Public: 07613327050592
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 07/31/2015
• Device Model Number: 5530-G-611
• Device Catalogue Number: 5530-G-611
• Device Lot Number: 1JK073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 74 KG