MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 28MM SZ D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	120-01-44
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years post op initial left tha, this 51 y/o female patient was revised.Head wore through the liner and the cup.Cup needed to be removed.Patient had a hip done in 2008 with m series steam nd acumatch cup.Used competitors device revision cup and exactech head.Patient was last know to be in stable condition following the event.Unable to obtain photos or x-rays.Product not returning - hospital won't release.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 120-01-44 - acumatch cluster cup porous coated 44mm.
Additional Manufacturer Narrative
The most likely underlying cause for the revision reported is a combination of risk factors specified in the hhe, including but not limited to use error 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.

• Brand Name: ACUMATCH GXL 15DEG LINER 28MM SZ D
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17757151
• Report Number: 1038671-2023-02283
• Device Sequence Number: 6664579
• Product Code: JDI
• UDI-Device Identifier: 10885862023063
• UDI-Public: 10885862023063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 120-01-44
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 05/10/2024
• 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
• Patient Age: 51 YR
• Patient Sex: Female