MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE MM ELEVATED RIM LINER USE WITH 60MM O.D. SIZE MM SHELL; PROSTHETIC, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: italy.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

It was reported that the insert does not fit in the seat.This event occurred outside of surgery and therefore there was no injury, no additional medical intervention, and no delay.No conditions contributed to the event and correct surgical technique was utilized.There is no additional information available at the time of this report.

Event Description

It was reported that during a procedure, the liner would not seat.There was no injury to the patient, medical intervention or delay reported.In addition, there was no contributing factors and the correct surgical technique was utilized.The procedure was completed using another liner.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Visual examination of the returned product identified anti rotation scallops show possible tool trim marks on the underside from manufacturing and deburring process.The scallops appear to have a chamfer from tool deburring and no indentation or deformation were noted.Elevated rim has indentation line.Taper between locking feature and scallops has indentation marks from attempted use.No other damage was noted.Anti rotation diameter surface was checked with the angled liner.Liner was found to seat in the gage as intended.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: 36MM I.D. SIZE MM ELEVATED RIM LINER USE WITH 60MM O.D. SIZE MM SHELL
• Type of Device: PROSTHETIC, 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: 18653160
• MDR Text Key: 334733363
• Report Number: 0001822565-2024-00395
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875201436
• Device Lot Number: 65941877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/05/2024; 04/19/2024
• Supplement Dates FDA Received: 03/08/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose