MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	ALT HA S CLR STD SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a female patient, initial right hip implanted on (b)(6) 2017, was brought back for right hip pain and was revised on (b)(6) 2022, approximately 4 years 10 months post the initial implant procedure.The femur was dislocated, the femoral head removed.The stem was checked and found to be loose and removed.Attention turned to the cup, the poly was removed with the help of a chisel.The cup was checked and found to be well fixed.A new liner was implanted.Attention turned back to femur where a size 8 alteon hps stem was implanted along with a new biolox head.Patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
Concomitants: 130-32-51 - nv gxl liner neutral, 32mm id group 1 cups serial : (b)(4).142-32-00 - cocr fem head 32mm +0 offset 12/14 serial: (b)(4).186-01-48 - integrip cc, cluster 48mm, g1 serial: (b)(4).Z-2117-2021.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h4, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported may have been the result of femoral stem loosening as reported, however this cannot be confirmed as pre-revision radiographs and relevant clinical information were not provided.User and patient-related considerations could not be evaluated from the information 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 STD SZ 5
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15540805
• Report Number: 1038671-2022-01238
• Device Sequence Number: 1885509
• Product Code: MEH
• UDI-Device Identifier: 10885862321077
• UDI-Public: 10885862321077
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 10/02/2022
• Device Model Number: ALT HA S CLR STD SZ 5
• Device Catalogue Number: 190-30-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female