MAUDE Adverse Event Report: EXACTECH, INC. COCR FEMORAL HEAD 28MM +5MM NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	100-28-05
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately six years post initial left tha, the 75 y/o female patient had a revision and the cup/head were removed.Patient's was revised only to exactech femoral head 36mm +10, but acetabular components were revised to competitor's devices.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images or x-rays.The devices are not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
Pending evaluation (d10) concomitant device(s): - acumatch gxl 15 deg liner 28mm sz f (cat# 132-28-26 / serial# (b)(6).- 50mm acumatch shell (cat# 120-01-50 / serial# (b)(6).- bone screw (cat# 120-65-20 / serial# (b)(6).

• Brand Name: COCR FEMORAL HEAD 28MM +5MM NECK
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19274846
• Report Number: 1038671-2024-01143
• Device Sequence Number: 15365952
• Product Code: JDI
• UDI-Device Identifier: 10885862023087
• UDI-Public: 10885862023087
• 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: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 100-28-05
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/08/2024
• Date Device Manufactured: 06/08/2017
• 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: 75 YR
• Patient Sex: Female