MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPSHO 6X97.5; 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 02/22/2022

Event Type  malfunction  

Event Description

It was reported while inspecting items in stock, the packages inner pouch seemed to be torn.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).(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

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 the reported event is confirmed.Sterility has not been compromised.Evaluation of the returned products confirmed damage to the sterile packaging pouch, outer sterile barriers are intact.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.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: TLOC 133 MP SP T1 PPSHO 6X97.5
• 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: 13792006
• MDR Text Key: 287410470
• Report Number: 0001825034-2022-00597
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304512993
• UDI-Public: (01)00880304512993(17)290715(10)6589370
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110400
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: 51-109060
• Device Lot Number: 6589370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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