MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	142-32-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related- mfr #1038671-2021-00357 report 1 of 2.H11.Additional manufacturer narrative- report 2 of 2.D10.Concomitant devices: (b)(6), 120-65-20 - bone screw 6.5mm dia x 20mm long, (b)(6), 130-32-52 - nv gxl linr, ntrl, 32mm id, group 2 cups, (b)(6), 164-12-12 - novation element ro x/o sz 12, (b)(6), 186-01-54 - integrip cc, cluster 54mm, g2.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
As reported, the male patient had his left poly insert and femoral head revised due to signs of osteolysis.The femur was dislocated, the cocr femoral head removed, stem was well fixed, turned to the cup and removed the liner.After attempts to remove with osteotome, a bone screw was placed to remove the liner.The cup was well fixed, and the patient received a new g2 lipped e poly and a new biolox head.Their left hip was revised approximately 7 years 3 months after their initial implantation.Patient was last known to be in stable condition following the event.There is no additional information available.
Additional Manufacturer Narrative
1038671-2021-00357.Correction: please disregard this report as it was reported in error.Event was previously reported under report #1038671-2021-00357.

• Brand Name: COCR FEM HEAD
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19741751
• Report Number: 1038671-2024-02391
• Device Sequence Number: 7991295
• Product Code: JDI
• UDI-Device Identifier: 10885862026835
• UDI-Public: 10885862026835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 03/16/2019
• Device Catalogue Number: 142-32-00
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male