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

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA FIXED BEARING CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE LEFT 20MM
• 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: 18054791
• Report Number: 0001822565-2023-03021
• Device Sequence Number: 6962537
• Product Code: JWH
• UDI-Device Identifier: 00889024554092
• UDI-Public: (01)00889024554092(17)240131(10)64286222
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• 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