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

Model Number	ACUMATCH 15 DEGREE LINER 32MM SZ G
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately eighteen years post initial left tha, the 82 y/o female patient had a revision due to the liner was worn away over time.The exactech femoral head was swapped for a 32mm cocr long neck +5, 11/13 taper.Surgeon removed the exactech liner and cemented in a competitor's liner.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The device is not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
Section d10: concomitant products: cocr femoral head 32mm +0mm neck (cat# 100-32-00 / serial# (b)(4)); 6.5x40mm bone screw (cat# 120-65-40 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: ACUMATCH 15 DEGREE 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16737529
• Report Number: 1038671-2023-00680
• Device Sequence Number: 17808193
• Product Code: JDI
• UDI-Device Identifier: 10885862023209
• UDI-Public: 10885862023209
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K993082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

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 Expiration Date: 07/10/2010
• Device Model Number: ACUMATCH 15 DEGREE LINER 32MM SZ G
• Device Catalogue Number: 132-32-07
• 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: 03/21/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2005
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1734-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 52MM ACET SHELL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female