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

Catalog Number	64811120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	04/24/2018
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 reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Broken mrh femur component (left knee).Revision surgery and replacment of the broken component.
Additional Manufacturer Narrative
An event regarding fracture involving an mrh femoral component was reported.The event was confirmed through medical review.Method & results: -device evaluation and results: not performed as product was not returned.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: review of these records confirms loss of fixation and fracture of the femoral component of a mrh tka did occur.However, the root cause cannot be determined as insufficient information was available.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: a review of the provided medical records and x-rays by a clinical consultant confirms loss of fixation and fracture of the femoral component of a mrh tka did occur.However, the root cause cannot be determined as insufficient information was available.Further information such as implant retrieval and material analysis, surgical implant records from the surgeries, outpatient office/clinic notes dated pre and post op x-rays/ imaging from the index and revision surgeries are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Broken mrh femur component (left knee).Revision surgery and replacment of the broken component.

• Brand Name: MRH KNEE FEM M 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: 7707788
• Report Number: 0002249697-2018-02255
• Device Sequence Number: 1405520
• Product Code: KRO
• UDI-Device Identifier: 07613327045154
• UDI-Public: 07613327045154
• Combination Product (Y/N): N
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 12/31/2018
• Device Catalogue Number: 64811120
• Device Lot Number: EFH8P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: 61 YR
• Patient Weight: 130