MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 14X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	6478-6-620
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	11/10/2020
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
The cemented shaft was separated from the femur.The item was explanted on (b)(6) and replaced by a gmrs femur (diatal femoral replacement).Initial implantation took place in 2017.Since one week instability was noticeable.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a duracon stem was reported.The event was confirmed based on medical review.Method & results: product 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 by a clinical consultant stated the following comment: "the cemented shaft was separated from the femur stem explanted on (b)(6) and replaced by a gmrs (distal femoral replacement)" undated x-ray lateral right knee: cemented long-stem hinged tka with distal tibial stem not visualized.An angular deformity is noted at the junction of the femoral stem and femoral component.Undated brief translation of user report: "increasing pain and instability right knee, ct, fracture between femoral component to cemented femoral shaft with gross loosening of femoral component indication for surgical treatment." no clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.While the undated x-ray appears to confirm the event description, insufficient information is presented to create a medical report for this case.Product history review: all 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: it was reported that the patient had fracture of device.The event was confirmed based on medical review.A review of the provided medical records by a clinical consultant stated the following comment: "the cemented shaft was separated from the femur stem explanted on (b)(6) and replaced by a gmrs (distal femoral replacement)" undated x-ray lateral right knee: cemented long-stem hinged tka with distal tibial stem not visualized.An angular deformity is noted at the junction of the femoral stem and femoral component.Undated brief translation of user report: "increasing pain and instability right knee, ct, fracture between femoral component to cemented femoral shaft with gross loosening of femoral component indication for surgical treatment." no clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.While the undated x-ray appears to confirm the event description, insufficient information is presented to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The cemented shaft was separated from the femur.The item was explanted on (b)(6) and replaced by a gmrs femur (diatal femoral replacement).Initial implantation took place in 2017.Since one week instability was noticeable.

• Brand Name: TI DUR REG FLUTED STEM 14X80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10926755
• Report Number: 0002249697-2020-02566
• Device Sequence Number: 11002797
• Product Code: JWH
• UDI-Device Identifier: 07613327044898
• UDI-Public: 07613327044898
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 10/31/2021
• Device Model Number: 6478-6-620
• Device Catalogue Number: 64786620
• Device Lot Number: 0048299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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