UNK - Nails: Tibial Antibiotic Coated

Description of Event or Problem

This report is being filed after the review of a clinical evaluation report (CER) from a related research activity database (DRRA) for Project Title: Long-term follow-up of antibiotic-coated titanium nails for infection-prophylaxis and in comparison to uncoated nails, conducted in sites in Germany, Belgium and the Netherlands. For this retrospective cohort study, medical records of patients treated between 2005 to 2023 with the UTN PROtect and/or ETN PROtect for tibia fractures or tibia revision cases will be examined. In comparison to this cohort, patients who received an uncoated tibia nail are examined as well. Complications reported were as follows:PROtect "[Unreamed Tibial Nail (UTN PROtect) / Expert Tibial Nail PROtect (ETN PROtect)]"Intra- and postoperative Complication:(Qty 2) Other: n=1 on label; n=1 off-label,(Qty 6) Implant failure (Breakage of parts of the fixation material): n=4 on label; n=2 off-label,(Qty 3) Secondary dislocation (Secondary loss of reduction): n=2 on label; n=1 off-label,(Qty 6) Compartment syndrome: n=6 on label,(Qty 1) Refracture/Peri-implant fracture: n=1 on label,(Qty 1) Hematoma requiring revision: n=1 on label,(Qty 30) Non-union development (fracture that is at least 9 months old and has not shown any signs of healing for 3 consecutive months): n=22 on label; n=8 off-label,(Qty 5) Thromboembolism: n=4 on label; n=1 off-label,(Qty 2) Deep vein thrombosis: n=2 on label,(Qty 5) Any systemic infection: n=4 on label; n=1 off-label,(Qty 29) Fracture Related Infection: n=18 on label; n=11 off-label,(Qty 51) Off-label use.Revision following the index surgery that led to the removal, exchange, or replacement of a UTN/ETN PROtect due to (Qty 53) :(Qty 9) Non-union,(Qty 15) Suspected infection, (Qty 2) Amputation, (Qty 1) Arthrodesis,(Qty 1) Preparation for prosthesis,(Qty 4) Other,(Qty 2) Malunion, (Qty 17) Implant irritation, (Qty 2) Implant migration.Uncoated (Expert Tibial Nail)Intra- and postoperative Complication:(Qty 1) Bleeding complication "[Iatrogenic vessel damage/excessive bleeding (vessel injuries requiring suture of a vessel, embolization or extension of the operation)]": n=1 on label,(Qty 2) Nerve damage: n=2 on label,(Qty 2) Other: n=2 on label,(Qty 4) Implant failure (Breakage of parts of the fixation material): n=2 on label and n=2 off-label,(Qty 2) Secondary dislocation (Secondary loss of reduction): n=2 on label,(Qty 5) Compartment syndrome: n=4 on label and n=1 off-label,(Qty 2) Hematoma requiring revision: n=2 on label,(Qty 9) Non-union development (fracture that is at least 9 months old and has not shown any signs of healing for 3 consecutive months): n=7 on label and n=2 off-label,(Qty 3) Any systemic infection: n=3 on label,(Qty 14) Fracture Related Infection: n=10 on label; n=4 off-label,(Qty 15) Off-label use.Revision following the index surgery that led to the removal, exchange, or replacement of a uncoated tibia nail due to:(Qty 5) Non-union,(Qty 7) Suspected infection, (Qty 2) Osteomyelitis, (Qty 1) Malunion,(Qty 2) Implant irritation.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11. Additional Manufacturer Narrative:D4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.