MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that during a hip procedure, the implant was opened and the tech realized the stem had punctured through the packaging.There was no direct contact with the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The product has been returned to zimmer biomet and the investigation is in process.Once the investigation as been completed, a follow-up mdr will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photos and returned product found the stem punctured the pouch and inner sterile blister.The outer blister exhibits stress damage and a crack consistent with puncture damage.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.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.A summary of the investigation has been sent to the customer.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: FEMORAL STEM PRESS-FIT COLLARLESS 12/14 NECK TAPER
• 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: 16795600
• MDR Text Key: 313825951
• Report Number: 0001822565-2023-01083
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024139305
• UDI-Public: (01)00889024139305(17)320517(10)65369261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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: 00786401520
• Device Lot Number: 65369261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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