MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 11X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/15/2019
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.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.
Event or Problem Description
Broken proximal femur distal stem gmrs.Pt presented with pain and instability.Update 08/15/2019: as reported in adverse consequences details "patient needed revision surgery to compensate for breakage".An operative report, pre-revision x-ray, and explant picture are provided.
Additional Manufacturer Narrative
An event regarding crack/fracture and instability involving a mrs stem was reported.The event of crack/fracture was confirmed through clinician review of the provided x-rays.The reported instability was not confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray provided confirms fracture, need additional information; primary operative report, clinical and past medical history and examination of explanted components.Device 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 reported lot.Conclusion: the reported instability was not confirmed.Review of the provided x-rays confirms fracture of the stem.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary operative reports, clinical and past medical history as well as examination of explanted components are required to complete the investigation and determine 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
Broken proximal femur distal stem gmrs.Pt presented with pain and instability.Update 15/august/2019 wg: as reported in adverse consequences details "patient needed revision surgery to compensate for breakage." an operative report, pre-revision x-ray, and explant picture are provided.

• Brand Name: MRS FEM STEM W/O BODY 11X127MM
• 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: 8991783
• Report Number: 0002249697-2019-03177
• Device Sequence Number: 18890964
• Product Code: KRO
• UDI-Device Identifier: 07613327048360
• UDI-Public: 07613327048360
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K040749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 02/28/2018
• Device Catalogue Number: 64853111
• Device Lot Number: 114639B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 82 YR
• Patient Weight: 81