MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the blister lid was difficult for the surgeon to open, so he opened it forcefully resulting in the implant falling out of the blister and dropping onto the floor, compromising it's sterility.It was also noted that the blister lid was not properly position as the heat seal was not properly sealed in one of the corners of the packaging.Attempts have been made and all available information has been provided.
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.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.The event cannot be confirmed.Visual evaluation of the device noted damage that likely occurred when the device fell to the floor.As the damage was not initially reported, no further investigation was performed.Evaluation of the returned product found the customer likely placed the retainer back into the tray incorrectly to take the pictures as there was no adhesive transfer from the tyvek lid onto the retainer and no reduction in seal width in the seal area.If the retainer was misaligned and sealed, there would be adhesive residue on the retainer lid.With neither of these issues present, it was determined that the retainer was placed correctly during the manufacturing process and photographed with incorrect placement.Sterility is considered breached as the device fell to the floor as a result of the packaging issue.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.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.

• Brand Name: PERSONA PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE E 8 MM THICKNESS
• Common Device Name: 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: 21067079
• Report Number: 0001825034-2025-00024
• Device Sequence Number: 8399128
• Product Code: HSX
• UDI-Device Identifier: 00880304818170
• UDI-Public: (01)00880304818170(17)271128(10)65754845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 42518200508
• Device Lot Number: 65754845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown