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

Model Number 6481-1-120

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one 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 Description

It was reported via medwatch report mw5096317: "broken plate.".

Manufacturer Narrative

This report is being closed as a duplicate of fda ref 0002249697-2020-01878.

Event Description

It was reported via medwatch report mw5096317: "broken plate.".

• Brand Name: MRH KNEE FEM M LFT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10669933
• MDR Text Key: 211336017
• Report Number: 0002249697-2020-02116
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045154
• UDI-Public: 07613327045154
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 6481-1-120
• Device Catalogue Number: 64811120
• Device Lot Number: C2A4B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention