MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 54MM GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	180-01-54
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Myalgia (2238); Osteolysis (2377); Implant Pain (4561)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the patient involved in (b)(4) meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: implanted with a lateralized liner, combination of largest available femoral head and/or thinnest available liner was used.The most likely underlying cause for the revision reported in (b)(4) is a combination of risk factors specified in hhe-2020-09-11-02 and being implanted for more than 10 years.However, the reported prosthesis wear or loosening cannot be confirmed from the reported information and the devices were not available for evaluation.
Event or Problem Description
As reported, the patient's complaints of their left hip initially began during walking and progressively worsened.The pain situation escalated and the client required inpatient care.The client was discharged with ongoing pain and later was revised.X-ray's showed a clear decentering of the prosthetic head and a very large osteolysis in the acetabulum as a sign of inlay wear.The radiological findings were confirmed during revision surgery.Because the socket was loose and osteolysis occurred due to the size, then the complete socket was changed to a revision hip cup with tab and iliac pin.The patient had to stay in the hospital two days longer because of their weakened state.The following rehabilitation was challenging for the patient.After rehabilitation the patient's symptoms have nearly entirely subsided, with only residual discomfort after prolonged walking.Furthermore, a misalignment has developed, leading to problems in the right hip as well.

• Brand Name: NV CROWN CUP CLSTR HOLE 54MM GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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 ; 3523771140
• MDR Report Key: 22034780
• Report Number: 1038671-2025-02078
• Device Sequence Number: 21203168
• Product Code: MEH
• UDI-Device Identifier: 10885862037022
• UDI-Public: 10885862037022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: Health Professional
• Device Expiration Date: 10/14/2017
• Device Catalogue Number: 180-01-54
• 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: 01/16/2024
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 10/17/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown