MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF FIX LAT BRG C6 LEFT; PROSTHESIS, KNEE

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 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and 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 an initial surgery, the nurse opened the packaging and noticed a hole in the first plastic layer.The implant could not be used as it may have not been sterile.The surgical technique was utilized.There was no surgical delay.Attempts have been made and all available information has been provided.

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: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 visual evaluation of the returned product found the thicker inner pouch exhibits scuffing.The thinner outer pouch has been punctured likely be the corner of the device.This complaint has been confirmed by evaluation of the returned product and provided photo.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The condition of the device when it left zimmer biomet is considered 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF FIX LAT BRG C6 LEFT
• Type of Device: PROSTHESIS, KNEE
• 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: 16952360
• MDR Text Key: 315451673
• Report Number: 0001825034-2023-01085
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279515189
• UDI-Public: (01)05019279515189(17)240527(10)516280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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 Expiration Date: 05/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 154333
• Device Lot Number: 516280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose