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 Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had hip prostheses from exactech implanted on the right on (b)(6) 2018.During outpatient check-ups, with mild load-related complaints, decentration of the prosthesis head was noticed for the first time in (b)(6) 2021 and an acetabular foreign body granuloma was suspected.Due to a traumatic acetabular fracture with acetabular loosening, a revision with acetabular replacement to a revision acetabular cup was carried out in (b)(6) 2023.In retrospect, it is likely that the fracture was at least exacerbated by the osteolysis caused by premature pe abrasion.Related to 1038671-2021-00269 (left hip revision).
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
Additional information: h3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear and/or osteolysis as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The revision reported was likely the result of prosthesis wear, osteolysis, bone fracture, and acetabular loosening.The sequence of event could not be determined from the available information.The devices were not returned for evaluation, and images and radiographs were not provided.H6: component code, investigation codes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d4, d6b, h4.B3: date of event is unknown.D6b: explant date is unknown.The revision reported was likely the result of prosthesis wear, osteolysis, bone fracture, and acetabular loosening.The sequence of event could not be determined from the available information.The devices were not returned for evaluation, and images and radiographs were not 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 ; 352377-1140
• MDR Report Key: 20277809
• Report Number: 1038671-2024-03643
• Device Sequence Number: 15307299
• Product Code: JDI
• UDI-Device Identifier: 10885862036995
• UDI-Public: 10885862036995
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 12/07/2022
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 05/15/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/22/2024; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2017
• 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
• Patient Age: 53 YR
• Patient Sex: Female