MAUDE Adverse Event Report: Exactech, Inc. ALT HA S CLR STD SZ 8; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu

Catalog Number	190-30-08
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event it was reported this patient underwent an initial right total hip arthroplasty.Subsequently, four and half (4.5) years later, the patient experienced worsening pain in right hip.As a result, the patient underwent a right knee revision procedure.The patient was revised to another manufacturer's construct.A revision operative report was provided.Intraoperatively, a loose femoral stem with no bony ingrowth was observed.The residual acetabulum was then inspected and found to be intact.The condition of the acetabular liner was not mentioned in the operative report.The patient was transferred to a bed and brought to the recovery room in stable condition.The patient tolerated the procedure well.There were no intra-operative complications.No further information is available.

• Brand Name: ALT HA S CLR STD SZ 8
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 50752471
• Report Number: 1038671-2026-01156
• Device Sequence Number: 13071796
• Product Code: MEH
• UDI-Device Identifier: 10885862654588
• UDI-Public: 10885862654588
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 11/01/2022
• Device Catalogue Number: 190-30-08
• 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: 04/13/2023
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 11/02/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male