MAUDE Adverse Event Report: EXACTECH, INC. NV CROWN CUP CLSTR HOLE 58MM GROUP 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	180-01-58
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with the reported event is within the scope of recall z-1729-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant devices: (b)(6), 136-36-53 - nv gxl lnr, +5lat, 36mm g3-56/58mm cups.(b)(6), 164-02-09 - element-stem, collarless w/ha, high offset, sz 9.(b)(6), 101-05-20 - 3.2mm drill bit 20mm 1pk.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.
Event or Problem Description
It was reported that a patient had a right total hip replacement (confirmed on x-ray) procedure and then was revised.Patient required revision surgery for issues including but not limited to polyethylene prosthesis wear.The stem was retained and a new head implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The mostly likely cause for the revision reported due to prothesis wear is a combination of risk factors including use error, implant positioning, implant size selection, and patient factors.However, this cannot be conclusively determined with the information provided.Concomitant devices: (b)(6), 136-36-53 - nv gxl lnr, +5lat, 36mm g3-56/58mm cups.(b)(6), 164-02-09 - element-stem, collarless w/ha, high offset, sz 9.(b)(6), 101-05-20 - 3.2mm drill bit 20mm 1pk.(b)(6), 180-01-58 - nv crown cup clstr hole 58mm group 3.(b)(6), 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6), 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.

• Brand Name: NV CROWN CUP CLSTR HOLE 58MM GROUP 3
• 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: 22506716
• Report Number: 1038671-2025-02501
• Device Sequence Number: 18457711
• Product Code: JDI
• UDI-Device Identifier: 10885862037046
• UDI-Public: 10885862037046
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 03/07/2020
• Device Catalogue Number: 180-01-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2024
• Initial Report FDA Received Date: 07/15/2025
• 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 Sex: Male