MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER KINECTIV NECK; PROTHESIS, HIPS

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 0100181480 metasulâ® ldhâ®, head, 48, code n, taper 18/20 2435670.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a right tha was performed.The patient was experiencing increasing pain and underwent a revision surgery eleven (11) years post implantation due to elevated metal ions.A large pseudotumor was identified, along with defects in the abductors.Corrosion was noted to the femoral head and trunnion.The head was explanted and replaced.This complaint was confirmed based on the provided medical records.Root cause unchanged.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

It was reported by legal that a patient underwent a metal-on-metal right total hip arthroplasty.The patient did well until presenting with increasing pain 11 years post implantation.Workup revealed a large pseudotumor, elevated cobalt and chromium levels, and adverse local tissue reaction.The patient was revised, during which, the surgeon found the large defects in the abductors with detachment from the greater trochanter.Corrosion was found on the femoral head with minimal evidence on the trunnion.Synovitis and metal debris were debrided from the joint.The shell and stem were found stable and left intact, and the large metal head was replaced with a dual mobility construct.

• Brand Name: UNKNOWN ZIMMER KINECTIV NECK
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17772304
• MDR Text Key: 323688408
• Report Number: 0001822565-2023-02564
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN ZIMMER KINECTIV NECK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female