MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 10X140MM; PROSTHESIS, HIP

Catalog Number 51-105100

Device Problem Packaging Problem (3007)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-02776, 0001825034-2022-02778.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 while inspecting the circulating items, the sterile packaging was found to be damaged.There was no patient involvement.It was reported that no further information is available.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h6.Reported event has been confirmed.Sterility has not been compromised.Visual evaluation of the returned product/provided photo(s) identified damage to the sterile packaging (blister).Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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 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.

• Brand Name: TPRLC XR T1 PPS 10X140MM
• Type of Device: PROSTHESIS, 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: 15976928
• MDR Text Key: 308185404
• Report Number: 0001825034-2022-02777
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517110
• UDI-Public: (01)00880304517110(17)300212(10)6741619
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120030
• 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: 01/27/2023

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 Catalogue Number: 51-105100
• Device Lot Number: 6741619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• 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