MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COCR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667)

Patient Problems Local Reaction (2035); Metal Related Pathology (4530)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure approximately thirteen (13) years post implantation due to instability and suspected trunnionosis due to an existing metal head on a metal stem neck trunnion.Explant of head revealed black debris inside head and around the rim, evidence to trunnionosis.Surgeon noted that the joint capsule was unusually worn away, most likely due to the metal issue.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2022-01062.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).

• Brand Name: UNKNOWN COCR HEAD
• Type of Device: PROSTHESIS, HIP
• 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: 14102892
• MDR Text Key: 289200577
• Report Number: 0001822565-2022-01061
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: 577250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• 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: UNKNOWN LINER; UNKNOWN SHELL; UNKNOWN STEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male