MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM17X155MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	64786720
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/01/2018
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.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Device not returned.
Event or Problem Description
It was reported that gmrs stem is broken after the patient fell, as seen on x-ray.The patient felt pain and limited knee joint motion.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a duracon stem was reported.The event was confirmed through clinician review of the medical records received.Method & results: -product evaluation and results: not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: lack of femoral condylar bone support of a mrh device since time of implantation in combination with a cemented proximal femoral stem extender has contributed to a huge overload condition on the connection between stem extender and mrh femoral device resulting in a fatigue fracture approximately 1-year after implantation.Revision surgery was required although there is no info about findings during revision surgery or the procedure performed.-product history review: indicated 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.Conclusion: a review of the provided medical records and/or x-rays by a clinical consultant indicated: lack of femoral condylar bone support of a mrh device since time of implantation in combination with a cemented proximal femoral stem extender has contributed to a huge overload condition on the connection between stem extender and mrh femoral device resulting in a fatigue fracture approximately 1-year after implantation.Revision surgery was required although there is no info about findings during revision surgery or the procedure performed.The exact cause of the event could not be determined based on the information provided.Device evaluation is required to complete the investigation for determining a root cause.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 gmrs stem is broken after the patient fell, as seen on x-ray.The paient felt pain and limited knee joint motion.

• Brand Name: TI DUR REG FLUTED STEM17X155MM
• 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: 8190080
• Report Number: 0002249697-2018-04105
• Device Sequence Number: 2026641
• Product Code: JWH
• UDI-Device Identifier: 07613327045048
• UDI-Public: 07613327045048
• Combination Product (Y/N): N
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 11/03/2021
• Device Catalogue Number: 64786720
• Device Lot Number: 0048392
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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; Other; Required Intervention
• Patient Age: 39 YR