MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE 12MMB ARTICULAR SURFACE W/HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown, 1 nonmod rhk tibia, unknown lot.Unknown, 12 b rhk poly, unknown lot.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.
Event or Problem Description
It was reported that a patient underwent a left/right knee arthroplasty on an unknown date.Subsequently, the patient is being considered for a poly revision with a pmi product on an unknown day for an unknown reason.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g4; g6; h1; h2; h3; h4; h6.The event cannot be confirmed.No product was returned, or pictures provided; visual and dimensional 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.X-rays were provided and reviewed by mmi they state the following: imaging findings - single ap standing view of both knees.There are changes of right knee arthroplasty with a hinged knee with cemented long femoral and tibial stems.No evidence of component loosening or fracture.The femoral component has mild overhang in relation to the native femoral condyles.The implant alignment appears standard in relation to the native femur and tibia.There appears to possibly be some mild valgus alignment of the right lower extremity however a total leg length study would be necessary to make this assessment.There is diffuse muscular atrophy in the visualized right lower extremity consistent with the given history of polio.Impression - hinged right knee arthroplasty with cemented long femoral and tibial stems.No evidence of component loosening or fracture.There is diffuse muscular atrophy in the visualized right lower extremity consistent with the given history of polio.The femoral component has mild overhang in relation to the native femoral condyles.The implant alignment appears standard in relation to the native femur and tibia.There is possibly some mild valgus alignment of the right lower extremity however a total leg length study would be necessary to make this assessment.The polyethylene insert is relatively thick in this particular implant.Increased thickness increases soft tissue tension-this has the potential to increase stability but decrease range of motion (rom), particularly the ability to achieve full extension, in some studies in the literature but often depends on individual factors and implant design.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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported, the patient is an extremely small female with polio who has the smallest rhk sizes available.Because of her condition, she has extremely limited range of motion and will require either a revision to a distal femoral replacement or proximal tibial replacement in order to increase her joint space and therefore gain mobility and function in her knee.She has no other adverse symptoms other than limited mobility and range of motion.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a2, a3, a4, b4, b5, b7, d5, d10, g3, h1, h2, h6,h11.Additional information was received and the investigation has been updated.Once the updated investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, b7, d4, d10, g1, g3, h1, h2.D10: 00588001202, right size b cemented option femoral component femoral plastic cap must be removed prior to implantation, 65430532.00588000102, size 1 precoat non-modular cemented tibial component, 65770711.00598801010, 10mm diameter 100mm length straight stem extension combined length 145mm, 65959076.42509902525, 2.5 mm female hex screw 25 mm length, 65905539.00590102000, headless trocar drill pin 3.2 mm diameter 75 mm length, 66269632.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROTATING HINGE 12MMB ARTICULAR SURFACE W/HINGE POST EXTENSION
• 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: 23008952
• Report Number: 0001822565-2025-03349
• Device Sequence Number: 10484840
• Product Code: JWH
• UDI-Device Identifier: 00889024199187
• UDI-Public: (01)00889024199187(17)280906(10)66226475
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00588002012
• Device Lot Number: 66226475
• Was Device Available for Evaluation?: No
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 09/18/2025; 10/31/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/07/2025; 10/17/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: Other
• Patient Sex: Female
• Patient Weight: 66 KG