MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL CEMENTED FEMORAL COMPONENT SIZE 4 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: concomitant devices: persona partial articular surface right medial size g 9 mm thickness, catalog #: 42528200709, lot #: 63826357, persona partial cemented tibial component size g right medial catalog #: 42538000702 lot #: 63982480, palacos r+g 2x20 catalog #: 66017775 lot #: 88434753.Report source: (b)(6).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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2021-02632.Investigation incomplete.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address pain, instability, polyethylene degradation and femoral component displacement approximately three years post-operatively.Attempts have been made, however, no additional information is available at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned devices identified that the articular surface exhibited signs of discoloration, wear and delamination.The femoral component exhibited signs of wear and being implanted.Review of x-rays provided noted malalignment with the femoral implant and articular surface medially positioned and the patient's bone quality appeared mildly osteopenic.The device history records were reviewed and no discrepancies were identified.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.

• Brand Name: PERSONA PARTIAL CEMENTED FEMORAL COMPONENT SIZE 4 RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12446405
• MDR Text Key: 270527989
• Report Number: 0001825034-2021-02630
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304808553
• UDI-Public: (01)00880304808553(17)280131(10)63813131
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161592
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000402
• Device Lot Number: 63813131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male