MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 03/03/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to loose ceramic in the maxeracup.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign: belgium.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was not returned by the surgeon.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.G4: this product is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states under 510k number k093549.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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.

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
• 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: 16865716
• MDR Text Key: 314524634
• Report Number: 0001822565-2023-01215
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024359536
• UDI-Public: (01)00889024359536(17)260430(10)63245877
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151506048
• Device Lot Number: 63245877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 100 KG