MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #2 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-202
Medical Device Problem Codes	Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
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 revision involving a triathlon femoral component was reported.The event was not confirmed.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: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.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.H3 other text : device not returned.

• Brand Name: TRIATHLON CR FEM COMP #2 R-CEM
• 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: 10815575
• Report Number: 0002249697-2020-02389
• Device Sequence Number: 1767641
• Product Code: MBH
• UDI-Device Identifier: 07613327040241
• UDI-Public: 07613327040241
• 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 Model Number: 5510-F-202
• Device Catalogue Number: 5510F202
• Device Lot Number: UNKNOWN
• 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: 11/10/2020
• 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