MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cocr fem head 36mm +10 offset 12/14 (cat# 142-36-10 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 3 yrs post-op the initial implant of the ltha, the (b)(6) y/o male patient kept dislocating.Patient revised and patient¿s joint deemed stable after reduction.Patient was last known to be in stable condition following the event.The device will not be returned due to hospital policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2 and h6 have been updated accordingly.As reported, approximately 3 yrs post-op the initial implant of the ltha, the 67 y/o male patient kept dislocating.Patient revised and patient¿s joint deemed stable after reduction.Patient was last known to be in stable condition following the event.The device will not be returned due to hospital policy.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient¿s condition, which caused the loosening, which caused the dislocations.

• Brand Name: ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12073242
• Report Number: 1038671-2021-00315
• Device Sequence Number: 4004452
• Product Code: JDI
• UDI-Device Identifier: 10885862024831
• UDI-Public: 10885862024831
• Combination Product (Y/N): N
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 09/22/2020
• Device Model Number: ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J
• Device Catalogue Number: 138-36-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 67 YR