MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FIXED BEARING CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE LEFT 20MM; 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 10/05/2023

Event Type  malfunction  

Event Description

It was reported that during knee arthroplasty when the articular surface was removed from the sterile packaging, a hair was identified on the surface of the device.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation of the picture provided identified hair-like debris on the implant.However, as the product was previously opened, the source of debris could not be confirmed.The device history records were reviewed and no discrepancies were identified.As the condition of the device was unknown when it left zimmer biomet, a definitive root cause could not be determined with the information provided.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 FIXED BEARING CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE LEFT 20MM
• 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: 18054791
• MDR Text Key: 327138331
• Report Number: 0001822565-2023-03021
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024554092
• UDI-Public: (01)00889024554092(17)240131(10)64286222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• 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,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512800420
• Device Lot Number: 64286222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• 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