MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 32MM SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-32-27
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 17 years post op initial right tha, this female patient was revised due to pain.Cup was removed.Competitors acetabular component implanted.No issues with surgery.Explants not available.Product not returning - explants not available.No other information provided.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 874746 118-01-02 - p-series pf plasma collarless sz 2 12/14.678566 120-01-54 - acumatch cluster cup porous coated 54mm.885625 120-65-20 - bone screw 6.5mm dia x 20mm long.702937 148-32-00 - 12/14 zirconia head 32mm +0mm neck.
Additional Manufacturer Narrative
Section h10: (h3) the most likely underlying cause for the revision reported is a combination of risk factors specified in an hhe and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code and problem code.

• Brand Name: ACUMATCH GXL 15DEG LINER 32MM SZ G
• 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: miguel sosa ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18360154
• Report Number: 1038671-2023-03033
• Device Sequence Number: 18066656
• Product Code: JDI
• UDI-Device Identifier: 10885862023247
• UDI-Public: 10885862023247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

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 Catalogue Number: 132-32-27
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/15/2024; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/23/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female