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

Model Number	ACUMATCH GXL 15DEG LINER 28MM SZ G
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately seventeen years post initial right tha, this (b)(6) male patient presented with apparent hip liner that wear leading to instability.Patient has a successful revision surgery.Patient hip liner and femoral head was removed and replaced.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device will be return.
Additional Manufacturer Narrative
Concomitant medical products: ceramic head 28mm +5 neck (cat# 2-28l / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of long-term prosthesis wear secondary to being implanted for 17 years.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 28MM 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: 14078463
• Report Number: 1038671-2022-00412
• Device Sequence Number: 5289675
• Product Code: JDI
• UDI-Device Identifier: 10885862023094
• UDI-Public: 10885862023094
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 06/27/2022

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: 08/23/2007
• Device Model Number: ACUMATCH GXL 15DEG LINER 28MM SZ G
• Device Catalogue Number: 132-28-27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2005
• 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