MAUDE Adverse Event Report: EXACTECH, INC. COCR FEM HEAD 32MM +7 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	COCR FEM HEAD 32MM +7 OFFSET 12/14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products nv gxl linr, ntrl, 32mm id, group 2 cups (cat# 130-32-52 / serial# (b)(4)).Alteon 6.5mm screw, 20mm (cat# 180-65-20 / serial# (b)(4)).Alt ha s clr ext sz 6 (cat# 190-31-06 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 3.5 years post initial tha, this male patient was brought back for right hip osteolysis.The patient was complaining of pain, and it was evident in the x rays.The femur was dislocated.The femoral head removed.The poly liner removed using a bone screw.The acetabular screw was removed.The cup was found to be well fixed.A new xle liner was implanted, 36mm id lipped.The stem was checked found to be loose.It was removed and a 19x245 monobloc was implanted with a 36+3.5 biolox head.There was no breakage of device and no surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays attached.The devices will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of an insufficient bond between the femoral stem and the femoral bone, which led to the reported pain and osteolysis.The most probable root cause associated with the reported event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• Brand Name: COCR FEM HEAD 32MM +7 OFFSET 12/14
• 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: 13732970
• Report Number: 1038671-2022-00237
• Device Sequence Number: 17408954
• Product Code: JDI
• UDI-Device Identifier: 10885862026859
• UDI-Public: 10885862026859
• 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: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: COCR FEM HEAD 32MM +7 OFFSET 12/14
• Device Catalogue Number: 142-32-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• 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: Male