MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH GXL 15DEG LINER 32MM SZ G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-32-27
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tha on (b)(6) 2009.The patient was revised on 10-oct-2023 due to the poly wearing down over time.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: (b)(6), 120-01-52 - acumatch cluster cup porous coated 52mm; (b)(6), 120-65-35 - bone screw 6.5mm dia x 35mm long; (b)(6), 142-32-00 - cocr fem head 32mm +0 offset 12/14; (b)(6), 160-21-09 - p-fit spline plas ex-off sz 9.H7: z-2133-2021.
Additional Manufacturer Narrative
Section h10: (h3) the most likely underlying cause for the revision reported is a combination of risk factors specified in an hhe and being implanted for more than 10 years.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.Section h11: the following sections have corrected information: (h6) component code: 734, bearings; 4755, part/component/sub-assembly term not applicable.
Additional Manufacturer Narrative
Corrections: h6 clinical code, h6 component code, h6 investigation findings, h6 investigation conclusions.

• Brand Name: ACUMATCH GXL 15DEG LINER 32MM 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18081013
• Report Number: 1038671-2023-02687
• Device Sequence Number: 12419306
• Product Code: JDI
• UDI-Device Identifier: 10885862023247
• UDI-Public: 10885862023247
• 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: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

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: 02/13/2012
• Device Catalogue Number: 132-32-27
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 04/18/2024; 11/18/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 04/30/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 83 KG