MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED TIBIAL TRAY LEFT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

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 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.

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 Description

No further event information available at the time of this report.

• Brand Name: PERSONA REVISION CEMENTED TIBIAL TRAY LEFT SIZE F
• Type of Device: 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
• MDR Text Key: 338659541
• Report Number: 0001822565-2024-01002
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024562806
• UDI-Public: (01)00889024562806(17)320314(10)65262884
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose