MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/28/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial knee surgery.Subsequently, the patient was revised due to a poly fracture approximately 5.5 years later.All fractured pieces were retrieved.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10: 42532007502 - tibia cemented 5 degree stemmed right size f - 63744239, 42540000038 - all poly patella cemented 38 mm diameter - 63530617, 42502006802 - femur cemented cruciate retaining (cr) narrow right size 10 - 63729716.Product has been received by zimmer biomet and 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 an initial right total knee arthroplasty.Subsequently, the patient was revised approximately 6 years later due to pain and noise.During the procedure, it was noted that the poly was fractured and worn.The poly was exchanged.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the returned product identified signs of heavy wear on the posterior lateral side of the proximal surface and found the distal surface of the locking features to be flared.Additional testing of the unit identified it as fractured potentially due to overloading.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the medical records identified: pain, a loud creaking sound in seated position, worn and fractured tibial poly, good rom, no definite abnormality seen in radiographs.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) RIGHT 10 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: 18002981
• MDR Text Key: 326474330
• Report Number: 3007963827-2023-00291
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468412
• UDI-Public: (01)00889024468412(17)221031(10)63829578
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522100810
• Device Lot Number: 63829578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG