MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-209
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/14/2020
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.
Event or Problem Description
It was reported that the patient fell on or about (b)(6) 2020 and their right knee was revised.A cs tibial bearing insert and cr femoral component were revised to a cemented ps femoral component, size 2 triathlon ts plus x3 poly, and modular distal femoral fixation peg.Spoke to rep: posterior insert wear was noted intra-operatively.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed by clinical review.Method & results -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: lateral x-ray shows evidence of significant posterior translation of the femoral component in relation to the tibia to the tibial component.This is consistent with wear of the posterior lip of the cs insert.The implants had been implanted 7 years prior.This degree of wear would not occur unless there was instability present over a considerable amount of time.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other similar events for the reported lot.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: lateral x-ray shows evidence of significant posterior translation of the femoral component in relation to the tibia to the tibial component.This is consistent with wear of the posterior lip of the cs insert.The implants had been implanted 7 years prior.This degree of wear would not occur unless there was instability present over a considerable amount of time.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient fell on or about (b)(6) 2020 and their right knee was revised.A cs tibial bearing insert and cr femoral component were revised to a cemented ps femoral component, size 2 triathlon ts plus x3 poly, and modular distal femoral fixation peg.Spoke to rep: posterior insert wear was noted intra-operatively.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• 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: 10808396
• Report Number: 0002249697-2020-02373
• Device Sequence Number: 17019447
• Product Code: MBH
• UDI-Device Identifier: 07613327045659
• UDI-Public: 07613327045659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 01/31/2022
• Device Model Number: 5531-G-209
• Device Catalogue Number: 5531G209
• Device Lot Number: LFN561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: 68 YR
• Patient Weight: 75