MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS SM FEM STEM 10 X 102MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mrs stem was reported.The event was confirmed by clinician review.Medical records received and evaluation: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem assembled with the femoral component with blood and tissue on them.The stem is broken into halves.Clinician review: a review of the provided medical information by a clinical consultant indicated: "provided x-ray confirms break.Need operative reports, office/clinical reports, examination of the explanted components.Etc." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.It was reported that the revision surgery took place due to a broken mrs femoral stem.The surgeon reported that the most likely cause or contributor was that the patient was moving furniture at the time.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, office/clinical reports, examination of the explanted components 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.Device not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to a broken mrs femoral stem.The surgeon reported that the most likely cause or contributor was that the patient was moving furniture at the time.Rep provided pre- and post-revision x-rays and explant pictures, and reported that no further information will be available.

• Brand Name: MRS SM FEM STEM 10 X 102MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8674329
• Report Number: 0002249697-2019-02179
• Device Sequence Number: 2947864
• Product Code: KRO
• UDI-Device Identifier: 07613327048278
• UDI-Public: 07613327048278
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 64853000
• Device Lot Number: TEC1195C2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/06/2019
• 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; Required Intervention
• Patient Age: 83 YR