MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEM HD 44MM TYPE 1 STD; PROSTHETIC, HIP

Model Number N/A

Device Problem Packaging Problem (3007)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the sterile packaging was damaged.No patient involvement was reported.There is no additional information available at the time of this report.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 g3 g6 h2 h3 h6 h10 visual evaluation of the returned product found the sterile blister is cracked.Sterility has been breached.This complaint has been confirmed by evaluation of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage.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: COCR FEM HD 44MM TYPE 1 STD
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17325352
• MDR Text Key: 319493120
• Report Number: 0001825034-2023-01614
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527898
• UDI-Public: (01)00880304527898(17)250914(10)3632103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 010001042
• Device Lot Number: 3632103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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