MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL (CR) STANDARD POROUS; PROSTHESIS, KNEE

Model Number	N/A
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	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Gh2: singapore.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 upon opening the implant box, there is opening on the sterile packaging.Opened another implant to proceed with surgery.No delay or harm to the patient was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the provided photos and returned product found the sterile packaging exhibits damage visually consistent with thermal damage.Sterility has been breached as the tyvek has lifted in one area of the outer blister.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event can be attributed to a packaging error.This complaint was confirmed by evaluation of the provided photos and returned product.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA FEMUR TRABECULAR METAL (CR) STANDARD POROUS
• 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: 19645881
• Report Number: 0001822565-2024-02195
• Device Sequence Number: 12406718
• Product Code: JWH
• UDI-Device Identifier: 00889024230767
• UDI-Public: (01)00889024230767(17)330507(10)65781941
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K122745
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 42502806202
• Device Lot Number: 65781941
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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: Prefer Not To Disclose