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

Model Number	WEDGE PLASMA S/O SZ 5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Periprosthetic fracture (4902)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: alt xle lnr extcov g4 36 (cat# 01-030-42-0436 / serial# (b)(4)); biolox delta femoral head 36mm od, +3.5mm (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, approximately twenty-six days post initial right tha, the 69 y/o female patient was brought back for right hip pain.Sales rep was unaware if patient fell or had any type of trauma to the hip.She fractured her lesser troch.The hip was dislocated, the femoral head and stem removed.The fracture was reduced with the use of a cable system.The poly liner was removed with the help of a bone screw.A new g4 alteon 36mm liner was implanted and a long smith and nephew hip stem was cemented in place.There was no breakage of device or surgical delay/prolongation.Patient was last know to be instable condition following the event.Photos and x-ray received, the devices are available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately twenty-six days post initial right tha, the69 y/o female patient was brought back for right hip pain.Sales rep was unaware if patient fell or had any type of trauma to the hip.She fractured her lesser trochanter.The hip was dislocated, the femoral head and stem removed.The fracture was reduced with the use of a cable system.The poly liner was removed with the help of a bone screw.A new g4 alteon 36mm liner was implanted and a long smith and nephew hip stem was cemented in place.There was no breakage of device or surgical delay/prolongation.Patient was last know to be instable condition following the event.Photos and x-ray received, the devices are available for evaluation.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information regarding fracture.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) - 01-030-01-0348 - alt cup clstr g3 sz 48 (b)(6) - 01-030-01-0450 - alt cup clstr g4 sz 50 (b)(6) - 01-030-42-0332 - alt xle lnr extcov g3 32 (b)(6) - 170-36-03 - biolox delta femoral head 36mm od, +3.5mm (b)(6) - 180-65-35 - alteon 6.5mm screw, 35mm (b)(6) - 180-65-35 - alteon 6.5mm screw, 35mm (b)(6) - 188-00-05 - wedge plasma s/o sz 5.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all from initial report-suspect device unknown), d10 (remove data), g4, h4 (remove manufacture date from initial report-unknown), h6: clinical code, component code, type of investigation, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately twenty-six days post initial right tha, the female patient was brought back for right hip pain.Sales rep was unaware if patient fell or had any type of trauma to the hip.She fractured her lesser troch.The hip was dislocated, the femoral head and stem removed.The fracture was reduced with the use of a cable system.The poly liner was removed with the help of a bone screw.A new g4 alteon 36mm liner was implanted and a long smith and nephew hip stem was cemented in place.There was no breakage of device or surgical delay/prolongation.Patient was last know to be instable condition following the event.Photos and x-ray received, the devices are available for evaluation.

• Brand Name: ALTEON HIP COMPONENTS
• 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: 16613004
• Report Number: 1038671-2023-00505
• Device Sequence Number: 17705918
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: WEDGE PLASMA S/O SZ 5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 02/05/2026
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 08/09/2023; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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: ALT CUP CLSTR G3 SZ 48; ALT CUP CLSTR G4 SZ 50; ALT XLE LNR EXTCOV G3 32; ALTEON 6.5MM SCREW, 35MM (2); SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female