MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Pitted (1460); Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently, the patient was revised approximately 5 years later due to femoral loosening.During the surgery, it was noted that poly was pitted and was also revised.There were no contributing conditions.There was no surgical delay.The surgical technique was utilized.Attempts have been made and all available information has been provided.

Manufacturer Narrative

(b)(4).Implant date : 2018.42502605801 - femur cemented cruciate retaining (cr) standard left size 5 - 63547079.42532006701 - tibia cemented 5 degree stemmed left size d - 64156330.Customer has indicated that the product will not be 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 event, please see associated reports: 3007963827-2023-00022.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified shows wear and possible pitting on the articular surface.As no products were returned further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the bones are otherwise unremarkable and the hardware appears intact.No fracture or dislocation.No loosening of the femoral component is confirmed radiographically.There's also possible polyethylene lining loss, given lack of spacing in the patellofemoral compartment.The overall fit and alignment of the implants is normal.A definitive root cause cannot 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.

Event Description

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

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
• Type of Device: 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: 16407900
• MDR Text Key: 309884499
• Report Number: 0001822565-2023-00419
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468917
• UDI-Public: (01)00889024468917(17)220531(10)63686912
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512100312
• Device Lot Number: 63686912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female