MAUDE Adverse Event Report: EXACTECH, INC. ALTEON HPS EXT SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	190-61-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 months post op the initial right tha, this 87 y/o female patient was revised due to stem loosening.Patient size 6 hps stem was explanted along with 32mm +3.5 head due to stem loosening.Patient acetabular cup, size 48, was also explanted along with the screws.Patient was last known to be in stable condition following the event.No other patient information/medical history provided.Devices are not returning, hospital keeps implants.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 170-32-03 - biolox delta femoral head 32mm od, +3.5mm.(b)(4) 01-030-40-0332 - alt xle lnr ntrl g3 32.(b)(4) 01-030-01-0348 - alt cup clstr g3 sz 48.(b)(4) 180-65-40 - alteon 6.5mm screw, 40mm.(b)(4) 180-65-25 - alteon 6.5mm screw, 25mm.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of early loosening possibly secondary to contributions from lateralization of the femoral stem within the canal resulting in a thin lateral cement mantle.However, this cannot be confirmed as the devices were not available for evaluation and limited clinical information was provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, g4, h6 (remove previous health effect-clinical code, investigation conclusions) and h11.The revision reported was likely the result of early loosening possibly secondary to contributions from lateralization of the femoral stem within the canal resulting in a thin lateral cement mantle.However, this cannot be confirmed as the devices were not available for evaluation and limited 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: ALTEON HPS EXT SZ 6
• 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 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 3523771140
• MDR Report Key: 15708098
• Report Number: 1038671-2022-01382
• Device Sequence Number: 4972791
• Product Code: JDI
• UDI-Device Identifier: 10885862526991
• UDI-Public: 10885862526991
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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 Model Number: 190-61-06
• Device Catalogue Number: 190-61-06
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 03/23/2023; 03/27/2026
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 04/14/2023; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: 87 YR
• Patient Sex: Female