MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 21X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	6478-6-655
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/16/2022
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.
Event or Problem Description
The following was reported: taper fracture between femur and stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a duracon stem was reported.The event was confirmed via clinician review of the provided x-ray and product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the mrh femoral knee was returned fractured at the female threaded component.The distal portion of the female threaded component was returned attached to the stem indicating that the device failed in bending fatigue.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to this pi including the product inquiry summary, ap and lateral x-rays of a cemented revision stemmed tka and op reports of a revision tka dated (b)(6) 2019 and an operative report of a subsequent revision on (b)(6) 2022.The event description from the product inquiries summary states: taper fracture between femur and stem.The undated x-rays demonstrate a transcerse fracture of the stem at its interface with the femoral boss.There is gross loosening of the femoral component which angulated on the lateral view.These findings are confirmed in the operative report from the second revision dated (b)(6) 2022.Fracture of a cemented revision femoral knee stem requiring revision surgery is confirmed.The root cause of this mechanical failure cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.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: visual inspection of the returned device noted the mrh femoral knee was returned fractured at the female threaded component.The distal portion of the female threaded component was returned attached to the stem indicating that the device failed in bending fatigue.A review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to this pi including the product inquiry summary, ap and lateral x-rays of a cemented revision stemmed tka and op reports of a revision tka dated (b)(6) 2019 and an operative report of a subsequent revision on (b)(6) 2022.The event description from the product inquiries summary states: taper fracture between femur and stem.The undated x-rays demonstrate a transcerse fracture of the stem at its interface with the femoral boss.There is gross loosening of the femoral component which angulated on the lateral view.These findings are confirmed in the operative report from the second revision dated (b)(6) 2022.Fracture of a cemented revision femoral knee stem requiring revision surgery is confirmed.The root cause of this mechanical failure cannot be determined from this limited documentation.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: taper fracture between femur and stem.

• Brand Name: TI DUR REG FLUTED STEM 21X80MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15540840
• Report Number: 0002249697-2022-01431
• Device Sequence Number: 1870001
• Product Code: JWH
• UDI-Device Identifier: 07613327044959
• UDI-Public: 07613327044959
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 05/31/2021
• Device Model Number: 6478-6-655
• Device Catalogue Number: 64786655
• Device Lot Number: 0046818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2016
• 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: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female