MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 10X140MM 0MM T1; 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 03/07/2022

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.Product is in process of being returned.

Event Description

It was reported while inspecting items in stock that the sterile packaging was damaged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event has been confirmed.Sterility has not been compromised.Visual evaluation of the returned product identified damage to the sterile packaging (blister and pouch).Evaluation confirmed there is debris inside the sterile packaging which is consistent with the appearance of porous coating.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event for black debris is likely to be due to transit damage causing the porous coating to shed from the implant, and a packaging design issue.Upon further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report should be voided.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 information on the reported event.

• Brand Name: TPRLC 133 T1 PPS HO 10X140MM 0MM T1
• 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: 13938220
• MDR Text Key: 288103690
• Report Number: 0001825034-2022-00698
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304491830
• UDI-Public: (01)00880304491830(17)290304(10)6498730
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200196
• 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
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• 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: 51-104100
• Device Lot Number: 6498730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1