MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK MAXERA 58MM ACETABULUM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

It was reported by a clinical study, a patient had a left total hip arthroplasty on an unknown date, due to primary osteoarthritis.Subsequently the patient underwent a revision which revealed a partially opened posterior capsule with a large amount of yellow fluid, the liner was misaligned without mobilization, taper modular junction wear, and signs of corrosion.The maxera cup was removed and replaced with a 2mm larger cup, with two screws and a 40mm ceramic insert.No additional information.

Manufacturer Narrative

(b)(4).Foreign source: canada.Doi: https://doi.Org/10.1186/s12891-022-05082-6.Reported event was confirmed due to the review of medical records.Visual examination of the provided pictures identified the explanted maxera cup with the liner and shell separated.Dark debris and wear is seen on the shell and liner, as well as dark tissues in the joint.The product is covered in bio-debris.No further evaluation can be made from the provided picture in the journal article (figures 8 and 9).Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: loosening of the hardware noted between the acetabular shall and the ceramic liner.This indicates loosening of the hardware.Intra-articular gas is noted, suggesting infectious cause and therefore the loosening may be related to infection.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 as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNK MAXERA 58MM ACETABULUM
• Type of Device: PROSTHESIS, HIP
• 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: 15614717
• MDR Text Key: 301825292
• Report Number: 0001822565-2022-02976
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/17/2022
• 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: UNK BIOLOX DELTA FEMORAL HEAD 44MM; UNK BIOLOX DELTA TAPER LINER; UNK TITANIUM SHELL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male