MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BLOCK AND SCREWS PRECOAT SIZE 6 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	5988-06-26
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Review of the feedback from the customer indicates that sterility has been breached as the inner and outer sterile blister were reported as cracked; however, this complaint cannot be confirmed as no product or photos were provided for review.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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.
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the outer sterile package was cracked along with the inner sterile package of the tibial block implant.The inner peel pack was intact so surgeon opted to implant the product as they did not feel there was a concern over sterility and a second implant of the same size was unavailable.No adverse events or patient impact have been reported as a result of the malfunction.All available information has been reported.

• Brand Name: TIBIAL BLOCK AND SCREWS PRECOAT SIZE 6 5 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17344425
• Report Number: 0001822565-2023-01925
• Device Sequence Number: 15088968
• Product Code: JWH
• UDI-Device Identifier: 00889024220638
• UDI-Public: (01)00889024220638(17)280930(10)64093684
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 5988-06-26
• Device Catalogue Number: 00598800626
• Device Lot Number: 64093684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose