MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 20MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while checking all the implants it was noticed the implant had arrived without sterile packaging when it was received at the hospital as the packaging was torn from the implant.This implant was never used or implanted.
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer had indicated that the product was being returned to zimmer biomet for investigation, but it has not yet been received.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Visual evaluation of the provided photo found the logo shrink wrap is missing.As this product was part of a loaner kit, it was likely removed during a prior case.The reported event states the device was not sterile.There is no indication in the photo that the carton is damaged, or that the sterile packaging is breached.The product was not returned, and no further evaluation can be performed.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; d9; g3; h2; h3; h10.Upon receipt of additional information of the reported event, it was determined to be not reportable.Visual evaluation of the returned product found damage to the outer carton and the inner sterile pouches are intact with no damage or breach to sterility.The initial reports should be voided.
Event or Problem Description
See h10 narrative.

• Brand Name: OSS TIBIAL POLY BEARING 20MM
• Common Device Name: 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: 12811429
• Report Number: 0001825034-2021-03119
• Device Sequence Number: 5484433
• Product Code: JDI
• UDI-Device Identifier: 00880304006492
• UDI-Public: (01)00880304006492(17)220912(10)115800
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: N/A
• Device Catalogue Number: 150414
• Device Lot Number: 115800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 01/20/2022; 03/29/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/24/2022; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown