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

Catalog Number	132-28-28
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/24/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total hip arthroplasty on (b)(6) 2006 and then experienced a revision surgical procedure on (b)(6) 2011 approximately 4 years and 10 months after initial implant.No other patient information / medical history reported.No images of the devices are provided.The device will not be returned.There is no other information available.
Additional Manufacturer Narrative
H10: pending investigation.These devices are used for treatments, not diagnosis.There is no other information available.Concomitants: 829218, 116-01-04 - acumatch c-series 12/14 sz 4.904883, 120-65-25 - bone screw 6.5mm dia x 25mm long.789828, 120-65-45 - bone screw 6.5mm dia x 45mm long.378274, 124-01-56 - acumatch cluster cup porous bead w/ha 56mm.4661203, 13a2101 - cemex system fast genta 70g.802570, 142-28-00 - cocr fem head 28mm +0 offset 12/14.6060114, 620-00-01 - accelerate prp kit 2 spin.F92f, kit-01 - cemex prep kit.756863, pc-17 - stem centralizer 17mm.

• Brand Name: ACUMATCH GXL 15DEG LINER 28MM SZ H
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19011095
• Report Number: 1038671-2024-00703
• Device Sequence Number: 3880638
• Product Code: LZO
• UDI-Device Identifier: 10885862023100
• UDI-Public: 10885862023100
• 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: 2006
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 09/28/2007
• Device Catalogue Number: 132-28-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/01/2024
• Date Device Manufactured: 09/30/2005
• 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 Sex: Unknown