MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE JJ NEUTRAL LINER; PROSTHESIS, HIP

Catalog Number 00875101132

Device Problem Packaging Problem (3007)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: canada.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.

Event Description

It was reported that upon opening the implant for a procedure, a hair was found in the sterile packaging.There was no harm or health consequences to the patient.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided photo found a hair-like debris on the device.The packaging has been opened; therefore, the source of the debris cannot be determined.This complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product has been opened.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

No additional event information to report at this time.

• Brand Name: 32MM I.D. SIZE JJ NEUTRAL LINER
• 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: 17169404
• MDR Text Key: 317533705
• Report Number: 0001822565-2023-01656
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 000889024149151
• UDI-Public: (01)000889024149151(17)270304(10)65310245
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00875101132
• Device Lot Number: 65310245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1