MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during the inspection of a loaner kit, it was discovered that the security seal of the package is opened.The product is in the unsealed package.There is no additional information available.

Manufacturer Narrative

Upon reassessment of the reported event, this report should be voided as no product or packaging failure occurred.Reported description indicates that the product was opened during surgery and returned to the loaner kit warehouse.

Event Description

Upon reassessment of the reported event, this report should be voided as no product or packaging failure occurred.Reported description indicates that the product was opened during surgery and returned to the loaner kit warehouse.

• Brand Name: BIOMET ILOK PRI TIB TRAY 67MM
• Type of Device: PROSTHESIS, KNEE
• 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: 12518531
• MDR Text Key: 272880536
• Report Number: 0001825034-2021-02677
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868247774
• UDI-Public: (01)00887868247774(17)300909(10)616100
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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: 141212
• Device Lot Number: 616100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2020
• 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