MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 48MM GROUP 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-48
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 132-28-51 - nv gxl lnr, lipped, 28mm id, group 1 cups: (b)(6).148-28-00 - 12/14 zirconia head 28mm +0mm neck: 2024038 monoblock stem: s/n.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2025-02808.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported a patient underwent a left hip total arthroplasty.Subsequently, thirteen and half (13.5) years later, the patient's x-rays indicated a malpositioned acetabular cup and polyethylene wear.The patient underwent a left hip revision four (4) days later.The acetabular cup, liner and femoral head were revised.The cup and liner were noted to be a competitor's implants.Intraoperatively, it was noted the patient needed bone graft due to poly wear, osteolysis and cup removal.There was an unexpected surgical delay of 30-45 minutes reported due to the acetabular cup being loose and falling out.As a result, a full acetabular component revision was needed instead of the planned revision of just the polyethylene components and the femoral head exchange.The patient was last known to be in stable condition following the event.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6a, h6 mdr section codes updated/corrected: a, b, c, e, f the revision reported was likely the result of prosthesis wear over the course of over 13 years of implantation, patient-related considerations, and a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) including impingement and edge loading.Acetabular cup loosening may be an additional reason for the reported revision, but this cannot be confirmed from the information provided as the devices were not returned for evaluation and no relevant clinical notes were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NV CROWN CUP CLSTR HOLE 48MM GROUP 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22859786
• Report Number: 1038671-2025-02809
• Device Sequence Number: 9212474
• Product Code: JDI
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2017
• Device Catalogue Number: 180-01-48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female