MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 10MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address pain, stiffness and infection approximately seven (7) months post-operatively.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant devices - persona trabecular metal two-peg porous tibial component left size e catalog #: 42530007101 lot #: 65068952, persona trabecular metal cruciate retaining standard porous femoral component catalog #: 42502806601 lot #: 65353953, nexgen trabecular metal standard primary patella catalog #: 00587806538 lot #: 64975784 report source - foreign: event occurred in australia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.The investigation is in process.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: 0001822565-2023-00692, 0001822565-2023-00693, 0001822565-2023-00694.Investigation incomplete.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the sterile certifications found the devices to be conforming with no applicable deviations.The devices were verified to have gone through acceptable sterilization following iso/aami/astm and eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet such as hospital/surgical environment, provider-related risk factors and/or patient comorbidities.As there were no indications of a product or process issue identified affecting implant safety or effectiveness, the implanted products are not identified to have contributed to the reported infection.

Event Description

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

• Brand Name: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE LEFT 10MM
• 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: 16553267
• MDR Text Key: 311401701
• Report Number: 3007963827-2023-00050
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469297
• UDI-Public: (01)00889024469297(17)260611(10)65053538
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150090
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 42512100810
• Device Lot Number: 65053538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG