MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED TIBIAL TRAY LEFT SIZE F; 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	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: event occurred in australia.The complainant 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.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that the tibial tray package was received damaged in transit and punctured through the plastic wrapping into the cardboard box.The contents of the packaging remained within the sterile plastic packaging.
Additional Manufacturer Narrative
The product has been confirmed to exhibit outer packaging and/or labeling damage that did not result in a loss of sterility or label legibility.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The reported event did not occur in an operating room or as part of a medical procedure.This complaint has been confirmed by review of the provided photo(s) and/or returned product.Based on the damage observed on the product, the damage to the outer packaging and/or labeling is consistent with damage from transit; therefore, the root cause of the reported event is attributed to transit damage.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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 REVISION CEMENTED TIBIAL TRAY LEFT SIZE F
• 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: 18975195
• Report Number: 0001822565-2024-01002
• Device Sequence Number: 15022840
• Product Code: JWH
• UDI-Device Identifier: 00889024562806
• UDI-Public: (01)00889024562806(17)320314(10)65262884
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• 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): 04/30/2024

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: 42542007501
• Device Lot Number: 65262884
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: Prefer Not To Disclose