MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 36MM SZ H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ACUMATCH GXL 15DEG LINER 36MM SZ H
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately twelve years post initial left tha, the 66 y/o male patient had a revision due to poly worn over time.Patient was revised with new acumatch 36mm size h 15 degree liner.Head also replaced with biolox delta 36mm +0.Pt deemed stable.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos received.The device is not available due to hospital policy.
Additional Manufacturer Narrative
Concomitant medical products: cocr fem head 36mm +0 offset 12/14 (cat# 142-36-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The revision reported was likely the result of a combination of long-term prosthesis wear and patient conditions secondary to being implanted for 12 years.However, this cannot be confirmed as the device was not available for evaluation.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: ACUMATCH GXL 15DEG LINER 36MM SZ H
• 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: 14740092
• Report Number: 1038671-2022-00686
• Device Sequence Number: 11331712
• Product Code: JDI
• UDI-Device Identifier: 10885862023391
• UDI-Public: 10885862023391
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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 Expiration Date: 03/04/2012
• Device Model Number: ACUMATCH GXL 15DEG LINER 36MM SZ H
• Device Catalogue Number: 132-36-28
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/19/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2008
• 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 Age: 66 YR
• Patient Sex: Male