MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MINIMA S; MINIMA S FEMORAL STEM #4

Model Number	4503.21.040
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the sterilization charts of the involved lot number: 2426083 - ster.2400220 no pre-existing anomalies were identified.This is the first and only complaint received regarding the lot number.A final report will be submitted when the investigation is concluded.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to infection.During the surgery stem, ceramic head, ceramic insert and delta tt cup were explanted.Only minima s standard stem #4 (product code: 4503.21.040, lot: 2426083 - ster.2400220) product information is known.Previous surgery performed on (b)(6) 2024.Event occurred in italy.
Additional Manufacturer Narrative
Checking the sterilization charts of the involved lot number (2426083 - ster.2400220) no pre-existing anomalies were identified, therefore we can state that the device was regularly sterilized before being placed on the market.The company has not recorded any other complaint due to infection on ster.Lot 2400220.The following information was requested to the complaint source but never provided: - pre-operative and post-operative x-rays.- patient data (gender, bmi, relevant pathologies).- pathogen responsible for the infection/results of the microbiological tests - code and lot numbers of the other devices involved.With the few available information, no further investigation is possible, other than the check of the device history records of the femoral stem involved, which confirmed the absence of pre-existing anomalies.This event is therefore classified as not product related.Pms data: according to company's pms data, the revision rate of minima-s stems (family codes 4503.21.Xxx, 4504.21.Xxx) due to infection is lower than 0,01%.No corrective action is needed following this complaint.The company will continue monitoring the market to promptly detect any further similar event.
Event or Problem Description
Hip revision surgery performed on (b)(6) 2025, due to infection.During the surgery, the following devices were explanted: - minima s standard stem #4 (product code: 4503.21.040, lot: 2426083 - ster.2400220).- ceramic head (product information unknown).- ceramic insert (product information unknown).- delta tt cup (product information unknown).The previous surgery took place on (b)(6) 2024.Patient is 59 years old.This event occurred in italy.

• Brand Name: MINIMA S
• Common Device Name: MINIMA S FEMORAL STEM #4
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; san daniele del friuli; udine, 30038
• MDR Report Key: 22093957
• Report Number: 3008021110-2025-00072
• Device Sequence Number: 6947919
• Product Code: MBL
• UDI-Device Identifier: 08033390079051
• UDI-Public: 08033390079051
• Combination Product (Y/N): N
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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?: No
• Device Model Number: 4503.21.040
• Device Lot Number: 2426083
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 01/19/2026
• Date Device Manufactured: 10/17/2024
• 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: Unknown