MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813111
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/07/2019
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.Device not returned.
Event or Problem Description
It was reported that the patient's right knee was revised due to a tibial periprosthetic fracture sustained in a fall.8 of the 10 devices in a gmrs/mrs/mrh knee construct (not the femoral component or stem) were revised to mrh devices.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a mrh baseplate was reported.The event was confirmed by medical review.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "provided x-ray confirms the periprosthetic fracture.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusion: it was reported that the patient's right knee was revised due to a tibial periprosthetic fracture sustained in a fall.The available medical records were provided to the consulting clinician for a review which was rejected stating provided x-ray confirms the periprosthetic fracture.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.The exact cause of the event could not be identified as insufficient information was available.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right knee was revised due to a tibial periprosthetic fracture sustained in a fall.8 of the 10 devices in a gmrs/mrs/mrh knee construct (not the femoral component or stem) were revised to mrh devices.

• Brand Name: MRH TIBIAL B/PLT KEEL SML 2
• 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: 8479555
• Report Number: 0002249697-2019-01521
• Device Sequence Number: 1253351
• Product Code: KRO
• UDI-Device Identifier: 07613327045314
• UDI-Public: 07613327045314
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/23/2019

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: 11/30/2018
• Device Catalogue Number: 64813111
• Device Lot Number: EFS9B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: 76 YR