MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH UNI-HOLE POROUS 58 MM; 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 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 the sterile package was damaged.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Visual evaluation of the provided photo(s) found a puncture in the sterile foil pouch.Sterility has been compromised.Reported event was confirmed by review of photographs provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is 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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated.The reported device was returned for further evaluation.Visual review of the returned device found indentation damage and one hole.Pouch was opened during technical evaluation and found plastic embedded in tm surface.The sterility, or breach therefore cannot be confirmed as the sterile blister was not returned for evaluation.Return of the product does not alter the previous investigation, as the root cause remains 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.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL WITH UNI-HOLE POROUS 58 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12816202
• MDR Text Key: 280827315
• Report Number: 0001822565-2021-03294
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024151451
• UDI-Public: (01)00889024151451(17)310313(10)64819068
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

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: 00875705800
• Device Lot Number: 64819068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/10/2021; 03/08/2022
• Supplement Dates FDA Received: 12/14/2021; 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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