MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR EXT SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	190-31-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10: (b)(6) 170-32-00 - biolox delta femoral head 32mm od, +0mm.(b)(6) 130-32-51 - nv gxl liner neutral, 32mm id group 1 cups.(b)(6) 180-65-20 - alteon 6.5mm screw, 20mm.(b)(6) 186-01-50 - integrip cc, cluster 50mm, g1.
Event or Problem Description
As reported by legal notification, approximately 5 years and 3 months post the initial right total hip replacement, the patient was revised due to possible femoral loosening.No further information provided.
Additional Manufacturer Narrative
H3: the most likely underlying cause for the loosening reported cannot be determined from the provided information.Radiographs provided do not show any indicators consistent with instability or loosening and no clinical information was provided.This follow-up report is being submitted to relay additional information.The following sections were updated: a2 this follow-up report is being submitted to relay corrected information.The following sections were corrected: h3.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.B3: date of event is unknown.D6b: explant date is unknown.Mdr section codes updated/corrected: f.Associated medwatch report: 1038671-2025-00271.The most likely underlying cause for the loosening reported cannot be determined from the provided information.Radiographs provided do not show any indicators consistent with instability or loosening and no clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALT HA S CLR EXT SZ 7
• 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 ; 3523771140
• MDR Report Key: 21036852
• Report Number: 1038671-2024-05071
• Device Sequence Number: 15561871
• Product Code: JDI
• UDI-Device Identifier: 10885862320964
• UDI-Public: 10885862320964
• Combination Product (Y/N): N
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2025

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: 05/24/2022
• Device Catalogue Number: 190-31-07
• 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: 04/13/2020
• Supplement Date Received by Manufacturer: 03/13/2025; 03/07/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/06/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male