MAUDE Adverse Event Report: EXACTECH, INC. ACUMATCH 0 DEGREE LINER 28MM 54/56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ACUMATCH 0 DEGREE LINER 28MM 54/56MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient original implants was in (b)(6) 2001.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient had a revision for an unknown reason.This was implanted in (b)(6) 2001.Surgeon used our m-series for years and was part of the design team.Photos and x-rays received.No additional information available.
Additional Manufacturer Narrative
Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.

• Brand Name: ACUMATCH 0 DEGREE LINER 28MM 54/56MM
• 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: 13624553
• Report Number: 1038671-2022-00228
• Device Sequence Number: 5257355
• Product Code: JDI
• UDI-Device Identifier: 10885862021946
• UDI-Public: 10885862021946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ACUMATCH 0 DEGREE LINER 28MM 54/56MM
• Device Catalogue Number: 130-28-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 06/16/2022
• 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: Required Intervention
• Patient Sex: Unknown