MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	12/10/2019
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
It was reported that the patient's left knee was revised after patient complaint of femoral pain.Intra-operatively, the condyle of the mrh femoral component was found to be completely broken off.Rep provided pictures of the explants and reported that no further information will be available.
Event or Problem Description
It was reported that the patient's left knee was revised after patient complaint of femoral pain.Intra-operatively, the condyle of the mrh femoral component was found to be completely broken off.Rep provided pictures of the explants and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via photographs.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:device was returned in used condition.Femoral component had blood and other biological material in a few areas.One of the condyles was fractured off.From the photographs provided there is evidence of crack/fracture for the device.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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.

• Brand Name: MRH KNEE FEM S LFT
• 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: 9560327
• Report Number: 0002249697-2020-00042
• Device Sequence Number: 2283409
• Product Code: KRO
• UDI-Device Identifier: 07613327045130
• UDI-Public: 07613327045130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 02/28/2020

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: 03/31/2018
• Device Model Number: 6481-1-110
• Device Catalogue Number: 64811110
• Device Lot Number: ECD8A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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: 47 YR