MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00588001501
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: 12mm height size e articular surface: catalog#00588005012, lot#64834891; 16mm diameter 100mm length straight stem extension combined length 145mm: catalog#00598801016, lot#64721298; size 4 precoat cemented tibial component: catalog#00588000400, lot#64739910; 14mm diameter 100mm length straight stem extension combined length 145mm: catalog#00598801014, lot#64710790; trabecular metal tibial cone, medium 36x31mm: catalog#00545001336, lot#64819407; trabecular metal femoral diaphyseal cone, 30mm, small, left: catalog#00545001730, lot#64532796; trabecular metal femoral metaphyseal cone, 35mm, medium, left: catalog#00545002135, lot#63858698; mathys gelatin cement restrictor c-plug size 14: catalog#237014, lot#20f0905009, qty#2; refobacin plus bone cem 2x40-3: catalog#3021170001-3, lot#y01bal0104.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-01883; 0002648920-2023-00218; 0001822565-2023-02512; 0001822565-2023-02513.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that a patient underwent a revision total knee arthroplasty.Approximately one year and nine months post-implantation, the patient began to experience pain, instability, immobility and moderate joint effusion.Diagnostic images revealed that the locking bar component of the articular surface had fractured.Subsequently, the patient underwent revision surgery.During the surgery, the knee joint was found to be uncoupled from the connector due to breakage of the locking bolt as well as dorsal dislocation of the articular surface and loosening of the cemented femoral component.The femoral components and articular surface were revised without complication.Due diligence is complete as multiple attempts have been made; all available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h10.H6: proposed component code: mechanical- (g04) femur visual and dimensional evaluation of the returned device found it to exhibit signs of being implanted (gouged/nicked/wear) and is covered in bone cement.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture, loosening, breakage of the hinge bolt, pain and instability noted.Radiographs show possible loosening.Root cause was unable to be determined.This complaint was confirmed for loosening and instability by the medical records.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 or Problem Description
No further event information at time of this report.

• Brand Name: LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT
• Common Device Name: 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: 17745658
• Report Number: 0001822565-2023-02511
• Device Sequence Number: 17467359
• Product Code: JWH
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)250331(10)64366826
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 00588001501
• Device Lot Number: 64366826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG