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

Model Number	FEMORAL HEAD
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 14.6 years post initial right tha, the male patient was brought in for a revision surgery.The surgeon changes the liner and head.The head was increased by 3.5mm.Patient was revised to exactech devices.The hip performed well and the surgeon was happy with the outcome.There was no breakage of the device or surgical delay/prolongation.Sales rep was unable to obtain images or x-rays.The devices are not available for evaluation as they were thrown out.
Additional Manufacturer Narrative
Section d10: concomitant products: a series liner.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, g3, g6 and h2 have been updated accordingly.Section b5: additional information received indicates that patient's revision was because of pain and stability.Sales rep does not have access to see what the original implants were.The implants that came out were not able to be read.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d1/d2a/d2b, d4, g3, h4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The most likely underlying cause for the revision reported is a combination of risk factors: such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17003073
• Report Number: 1038671-2023-01142
• Device Sequence Number: 7378344
• Product Code: JDI
• UDI-Device Identifier: 10885862023247
• UDI-Public: 10885862023247
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,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: 04/10/2012
• Device Model Number: FEMORAL HEAD
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 01/02/2025; 04/15/2025
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/21/2023; 01/06/2025; 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male