MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30MM L; PROSTHESIS, KNEE

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

It was reported when the hcp opened the item during the case and there was unknown white sticky substance on inner packaging.This was deemed to be contaminated so, it was not used.There was no patient harm or impact reported.

• Brand Name: PERSONA STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30MM L
• 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: 19181954
• MDR Text Key: 341399479
• Report Number: 0001822565-2024-01402
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)340108(10)66461480
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

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: 42557000114
• Device Lot Number: 66461480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose