MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOW SCREW; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 04/12/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient¿s knee was revised approximately 9 years post implantation due to implant breakage.During the surgery, the surgeon noted difficulty removing the anchoring screw of the inlay due to the hex head was worn out.A tuberosity osteotomy was performed.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records received.Patient underwent revision surgery for loosening.During the surgery, the surgeon noted difficulty removing the anchoring screw of the inlay due to the hex head was worn out.A tuberosity osteotomy was performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOW SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8631868
• MDR Text Key: 145773174
• Report Number: 0001822565-2019-02180
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN FEMORAL COMPONENT; UNKNOWN TIBIAL BEARING; UNKNOWN TIBIAL TRAY; UNKNOWN FEMORAL COMPONENT; UNKNOWN TIBIAL BEARING; UNKNOWN TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75