MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZIMMER UNICOMPARTMENTAL M/G UNIHEADED SCREW; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/01/2019

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012 a zimmer unicompartmental knee system was implanted in the right knee.The system included the femoral component high flex precoat right medial size e, tibial component precoat right medial size 4, 9 mm articular surface size 4, m/g uniheaded screw and bone cement from a competitor.The knee was re-examined in or about (b)(6) 2014, no issues found.By (b)(6) 2019, it was determined that his knee implant had fractured.Revision surgery was performed on (b)(6) 2019.The surgery involved extreme risks including potential limb amputation, additional surgeries, blood clots, and death.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this is a legal case.All communication will be through the legal department.The medical investigation task will be closed until the documents come in to be reviewed.At that time the medical investigation will be re-opened and the investigation will proceed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ZIMMER UNICOMPARTMENTAL M/G UNIHEADED SCREW
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10438563
• MDR Text Key: 203975341
• Report Number: 1020279-2020-04146
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention