MAUDE Adverse Event Report: EXACTECH, INC. COCR FEMORAL HEAD 40MM, +0 OFFSET 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	142-40-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number d10: 101-05-03 - drill bit 1 pk 4.5mm dia x 32mm lng; 132-40-54 - nv gxl liner lipped 40mm id, group 4 cups; 164-01-13 - element-stem, collarless w/ha, std offset, sz 13; 180-01-60 - nv crown cup clstr hole 60mm group 4; 180-65-25 - alteon 6.5mm screw, 25mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03529.The most likely underlying cause for the revision reported is prosthesis wear and fracture and a combination of risk factors such as use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential).However, this cannot be confirmed from the reported information and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".
Event or Problem Description
It was reported that approximately 77 months after a total replacement procedure, the patient underwent a revision procedure to address prosthesis wear osteolysis.Post operative diagnosis noted wear of the implant.A number of variables including use error, implant positioning, implant size selection, and patient factors (fitness for surgery, biomechanics, activity level and local tissue oxidation potential) could have all contributed to the increased trend in wear/osteolysis related complaints.Additionally, increased shelf oxidation resulting from the use of nylon vacuum bags without evoh could also have contributed to the increased trend in wear/osteolysis.No further issues or complications were reported.No additional information is available.

• Brand Name: COCR FEMORAL HEAD 40MM, +0 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 66th ct; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21252702
• Report Number: 1038671-2025-00476
• Device Sequence Number: 20884550
• Product Code: JDI
• UDI-Device Identifier: 10885862206923
• UDI-Public: 10885862206923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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: 04/29/2018
• Device Catalogue Number: 142-40-00
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 05/01/2013
• 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; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Unknown