MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Joint Dislocation (2374)

Event Date 04/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: 00585002014 64510506 articular surface with segmental hinge post; 00599003420 63553256 femoral augment; 00598801112 63542117 stem extension straight; 00598802017 63082997 stem extension offset. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03263.

Event Description

It was reported the patient underwent an initial right total knee arthroplasty. Subsequently, the patient was revised approximately 2 years post implantation through a 2 stage revision to a rotating hinge knee. Approximately 6 days post revision, it was reported the patient¿s leg failed and he slipped off the bed when he got up in his room on the ward. The patient hypereflexed his right knee while sutures were still in situ from the previous revision. He had an open reduction of a joint dislocation with lavage and reconstruction of the capsular ligament of the knee joint. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10550765
• MDR Text Key: 207512707
• Report Number: 0001822565-2020-03262
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00585001296
• Device Lot Number: 64510164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 09/17/2020 Patient Sequence Number: 1