MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH CLUSTER CUP POROUS COATED 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	120-01-50
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 120-65-35 - bone screw 6.5mm dia x 35mm long 1261623.132-28-26 - acumatch gxl 15deg liner 28mm sz f 841168.160-20-13 - pf splined plasma sz 13 806827.142-28-93 - cocr fem head 28mm -3.5 offset 12/14 756745.
Event or Problem Description
As reported, approximately 15 years post op initial right tha, this 79 y/o female patient was revised due to the acetabular components becoming loose.Patient's femoral head was revised using exactech.170-32-50, biolox delta option head, 32mm and 170-50-03, biolox delta adapter, 12/14 +3.5mm, the acetabular side were revised to competitors device.Patient was last known to be in stable condition following the event.Unknown medical history.No pictures or x-rays provided.Device not being returned due to hospital policy.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.

• Brand Name: ACUMATCH CLUSTER CUP POROUS COATED 50MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17343117
• Report Number: 1038671-2023-01695
• Device Sequence Number: 6524061
• Product Code: JDI
• UDI-Device Identifier: 10885862019721
• UDI-Public: 10885862019721
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 08/05/2009
• Device Catalogue Number: 120-01-50
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2004
• 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
• Patient Age: 79 YR
• Patient Sex: Female