MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE GH 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign source: (b)(6).The clinic reporting this issue is: (b)(6).Customer has indicated that the product will not 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 or Problem Description
It was reported that the clinic had concerns about the sterility of the device due to the packaging.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable, as there was no issue with the sterility of the device.
Event or Problem Description
It was reported the surgeon was concerned about the sterility of the package since the packaging design has changed for this product and he was unaware of the change, and did not want to use the product.However, there was no real issue with the package.Upon reassessment of the reported event, it was determined to not be reportable, as there was no issue with the sterility of the device.

• Brand Name: ARTICULAR SURFACE SIZE GH 12 MM HEIGHT
• 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: 14490793
• Report Number: 0001822565-2022-01545
• Device Sequence Number: 4735756
• Product Code: JWH
• UDI-Device Identifier: 00889024212138
• UDI-Public: (01)00889024212138(17)270227(10)65422762
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• 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
• Report Date (Section B): 06/28/2022

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 Model Number: N/A
• Device Catalogue Number: 00596405012
• Device Lot Number: 65422762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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