MAUDE Adverse Event Report: LIMACORPORATE S.P.A AMF TT CONES; TT CONE CENTRAL TIBIA DIA. 18

Model Number	6C21.14.180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records did not identify any pre-existing deviation on involved lots possibly contributing to reported issue.Review of complaint database did not identify further similar events for involved sterilization lots.From follow-up communication, sales representative confirmed that original wound was closed and patient dollowed proper antibiotic therapy after previous surgery, explanted components were in normal condition.Taking into account all the gathered information, the manufacturer has no evidence to consider the event as product related.Based on the available pms data, the revision rate of amf tt cones, belonging to the family product codes 6c10/6c12/6c21/6c22.14.Xxx due to infection is around 0.02%.According to the investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery performed on (b)(6) 2026 due to infection.Previous surgery was on (b)(6) 2026 when another manufacturer knee implants used with the amf tt cones: cone central femur d.18 (pn 6c10.14.180, lot 2401822 sterilization (b)(4)).Cone central tibia d.18 (ps 6c21.14.180, 2536933 sterilization (b)(4)).After few months patient developed an infection and the pre-existing amf tt cones were replaced with new ones with dia 21mm (pn 6c10.14.210 and 6c21.14.210 respectively).The whole implant from the third-party manufacturer was also replaced.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1960.The event occurred in the united states.

• Brand Name: AMF TT CONES
• Common Device Name: TT CONE CENTRAL TIBIA DIA. 18
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25903356
• Report Number: 3008021110-2026-00267
• Device Sequence Number: 12225752
• Product Code: JWH
• UDI-Device Identifier: 08033390230919
• UDI-Public: 8033390230919
• Combination Product (Y/N): N
• PMA/510(K) Number: K234011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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
• Device Model Number: 6C21.14.180
• Device Lot Number: 2536933
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2026
• 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 Age: 66 YR
• Patient Sex: Male