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

Catalog Number	190-21-07
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 170-32-07 - biolox delta femoral head 32mm od, +7mm 6218314.01-030-40-0332 - alt xle lnr ntrl g3 32 a150675.01-030-01-0348 - alt cup clstr g3 sz 48 a381411.180-65-30 - alteon 6.5mm screw, 30mm s399575.
Event or Problem Description
As reported, the patient had an initial left tha on (b)(6) 2023 and has since subsided.The patient was revised on (b)(6) 2023 and implanted with competitor's devices.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.
Event or Problem Description
As reported, the patient had an initial left tha and has since subsided.The patient was revised and implanted with competitor's devices.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: a, b, c, d, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of the reported femoral stem subsidence.The cause for the femoral stem subsidence was likely due to patient-related conditions.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ALT HA S NOCLR EXT SZ 7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17774912
• Report Number: 1038671-2023-02313
• Device Sequence Number: 20705612
• Product Code: MEH
• UDI-Device Identifier: 10885862321220
• UDI-Public: 10885862321220
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 01/24/2026
• Device Catalogue Number: 190-21-07
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female