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	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the (b)(6) y/o female patient presented to the surgeon with pain in the left hip due to poly wear.The 15* 28mm acumatch gxl liner was revised to a 15* 32mm xle liner.There was no surgical delay.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities, which led to polyethylene wear after being implanted for over 13 years.However, this cannot be confirmed as the device was not available for evaluation.

• 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: 12331616
• Report Number: 1038671-2021-00392
• Device Sequence Number: 16850568
• Product Code: JDI
• UDI-Device Identifier: 10885862023094
• UDI-Public: 10885862023094
• 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: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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 Model Number: ACUMATCH GXL 15DEG LINER 28MM SZ G
• Device Catalogue Number: 132-28-27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 07/11/2022
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 117 KG