MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM12X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786690
Medical Device Problem Codes	Break (1069); Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray confirms fractured femoral stem.Cause not established.Need revision operative report and examination of explanted components.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 reported lot.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's right knee was revised due to aseptic loosening of the femur and tibia, as well as a broken femoral stem at the stem/ offset bolt interface.Rep reported the patient's entire knee was revised.
Event or Problem Description
It was reported that patient's right knee was revised due to aseptic loosening of the femur and tibia, as well as a broken femoral stem at the stem/offset bolt interface.Rep reported the patient's entire knee was revised.
Additional Manufacturer Narrative
This report has been updated to reflect femoral component loosening.The referenced fractured femoral device confirmed by x-ray is reported in a separate mdr.An event regarding femoral and tibial loosening as well as a fracture between the femoral stem and offset component involving a (tibial) stem extender component was reported.The event was not confirmed.Device evaluation and results: not performed as the device was not returned for evaluation.A review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem; need revision operative report and examination of explanted components.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.Review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms fractured femoral stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including revision operative report and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TI DUR REG FLUTED STEM12X155MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7908430
• Report Number: 0002249697-2018-03039
• Device Sequence Number: 16557539
• Product Code: JWH
• UDI-Device Identifier: 07613327044997
• UDI-Public: 07613327044997
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 64786690
• Device Lot Number: T3183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/26/2018
• 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: 72 YR
• Patient Weight: 91