MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); Swelling/ Edema (4577)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - persona natural trabecular metal two-peg porous fixed bearing tibial component right size d catalog #: 42530006702 lot #: 64982014, persona trabecular metal cruciate retaining standard porous femoral component catalog #: 42502805402 lot #: 64519943.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a knee arthroplasty revision of the articular surface to address post-operative instability and swelling/effusions.During the procedure, it was noted that the articular surface being removed was not compatible with the femoral component.The instability immediately resolved with a new articular surface.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.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Pictures provided showed an explanted tibial bearing.The device history records were reviewed and no discrepancies were identified.The reported products were reviewed for compatibility and determined that the femoral and articular surface components were not compatible with one another.The root cause of the reported issue is attributed to off label use of the device.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 MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16495185
• MDR Text Key: 310788268
• Report Number: 3007963827-2023-00036
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468030
• UDI-Public: (01)00889024468030(17)260405(10)64990007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522100312
• Device Lot Number: 64990007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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 Sex: Female