MAUDE Adverse Event Report: EXACTECH, INC. CUP, CLUSTER-HOLE, 46MM GROUP 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-46
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 41 months after a right total hip replacement procedure, the patient underwent a revision procedure to address eccentric polyethylene wear and osteolysis.Initial surgery and revision surgery operative notes were provided.Findings indicated extreme synovitis and metallosis, and the surgeon was able to remove the cup with his fingers.The surgeon performed a revision of the acetabular cup/liner and femoral head.Patient was taken back to the postanesthesia recovery room in a stable fashion.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6), - 130-28-50 - gxl nuetral liner, g0 28mm id, (b)(6), 101-45-20 - 4.5mm drill bit 20mm, (b)(6), 142-28-00 - cocr fem head 28mm +0 offset 12/14, (b)(6), 180-01-46 - cup, cluster-hole, 46mm group 0, (b)(6), 164-13-09 - novation element ro s/o col sz 9, (b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00765.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: h6: type of investigation, investigation findings.The most likely underlying cause for the revision due to early prosthesis wear reported is 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).The metallosis reported may have been due to unintended contact between the femoral head and the acetabular cup.Acetabular cup loosening may be an additional reason for the reported revision.However, the cause and sequence of events cannot be confirmed from the reported information because the revised devices were not available for evaluation and no images or radiographs were provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CUP, CLUSTER-HOLE, 46MM GROUP 0
• 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: 21549292
• Report Number: 1038671-2025-01475
• Device Sequence Number: 4474761
• Product Code: JDI
• UDI-Device Identifier: 10885862036988
• UDI-Public: 10885862036988
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 07/19/2020
• Device Catalogue Number: 180-01-46
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 07/22/2015
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female