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

Model Number 42-5221-009-12

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: natural tibia trabecular metal two-peg porous fixed bearing right size g: catalog#42530007902, lot#64533097; femur trabecular metal cruciate retaining (cr) standard porous: catalog#42502806602, lot#63662618; all-poly patella cemented 35 mm diameter: catalog#42540200035, lot#64776074.Report source: foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product was retained for analysis by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Approximately one year post implantation, the patient presented with clicking in the knee.Subsequently, the patient was revised due to articular surface dissociation due to lateral laxity.The polyethylene component was revised without complication.It was reported that no further information is available.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual examination of the provided picture did not identify any noticeable damage.The device was not returned for further evaluation.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT
• 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: 14711837
• MDR Text Key: 294134211
• Report Number: 3007963827-2022-00167
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468511
• UDI-Public: (01)00889024468511(17)250331(10)64716704
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5221-009-12
• Device Catalogue Number: 42522100912
• Device Lot Number: 64716704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 85 KG