MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR EXT SZ 8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT HA S CLR EXT SZ 8
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products:¿ integrip cc, cluster 54mm, g2 (cat# 186-01-54 / serial# (b)(4).Nv gxl liner neutral, 36mm id, group 2 cups (cat# 130-36-52 / serial# (b)(4).Biolox delta femoral head, 36 mm (cat# 170-36-03 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2018, patient underwent a left hip arthroplasty due to severe osteoarthritis in his left hip.Following the left hip arthroplasty, patient presented to surgeon complaining of left sided hip pain.An x-ray examination of patient's left hip was ordered and showed a lucent line about the femoral stem of the left device.Importantly, surgeon noted that patient's left femoral stem was "grossly loose." on or about (b)(6) 2022, patient underwent left hip revision surgery due to aseptic loosening and a failed left total hip arthroplasty.Surgeon specifically noted in the revision operative report that "the stability of the "[femoral]" stem was checked and found to be loose".
Additional Manufacturer Narrative
H10.Updated/additional information ¿ g1.G2.G4.H6.The revision reported may have been the result of pain and femoral stem loosening that occurred over approximately 3 years and 9 months of use.The stem loosening may have been the result of an insufficient bond between the femoral stem and the femoral bone, which likely contributed to the reported pain.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e, g2 (correcting initial report), h6: clinical codes, component code, types of investigation and investigation findings code.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 8
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16183945
• Report Number: 1038671-2023-00036
• Device Sequence Number: 2428691
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 12/27/2022
• Device Model Number: ALT HA S CLR EXT SZ 8
• Device Catalogue Number: 190-31-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 04/24/2024; 04/22/2026
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 05/06/2024; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2017
• 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 Sex: Male