MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MINIMA S; MINIMA S FEMORAL STEM #8

Model Number	UNCEMENTED STEM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery occurred on (b)(6) 2024, due to subsidence of femoral implant.Previous surgery performed on (b)(6) 2023.Patient 73 years old.The following medical devices were explanted: · minima s standard stem #8 (product code.4503.21.080, lot.2306913 - ster.(b)(4)) - sold in us.· biolox delta femoral head (product code: 5010.42.403, lot.7011759464) - sold in us.· delta cup - neutral liner (product code:5885.54.262, lot.2105704 - ster.(b)(4)) - not sold in us.· delta tt acetabular cup (product code: 555215620, lot.2102953 - ster.(b)(4)) - sold in us.
Additional Manufacturer Narrative
By checking the dhr of the involved lot.Number, no pre-existing anomaly was detected on the devices manufactured with this lot number.We will submit a final report once the investigation will be completed.
Additional Manufacturer Narrative
By checking the dhr of the involved lot.Number 2306913 and ster.(b)(4), no pre-existing anomaly was detected on the devices manufactured with this lot number.According to our records, at least 12 pieces out of 20 minima s standard stem #8 (product code 4503.21.080) with lot.2306913 and ster.(b)(4) have been implanted, and this is the only complaint received on this lot.Limacorporate did not receive pre- and post-operative x-rays of revision surgery and previous surgery.Also, the clinical information of the patient was not available.The explanted devices were returned to limacorporate for further investigation.From a visual inspection of the returned explant, no relevant observations could be made in relation to the described event.It is presumed that the reported event is related to a surgical factor.Based on the few available information, it is not possible to determine the root cause of the event with certainty.Considering that: · the review of the dhrs revealed no pre-existing anomalies in the involved lot #.· this is the first and only complaint received on the lot #.· from a visual inspection of the explant no relevant findings could be made.We may conclude that the event is not product-related.We suppose the reported issue is related to a surgical factor.Pms data: according to limacorporate pms data the revision rate of minima s stem (code: 4503.21.Xxx and 4504.21.Xxx) due to subsidence is nearly (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.
Event or Problem Description
Revision surgery occurred on (b)(6) 2024, due to subsidence of femoral implant.Previous surgery performed on (b)(6) 2023.Patient 73 years old.The following medical devices were explanted: · minima s standard stem #8 (product code.4503.21.080, lot.2306913 - ster.(b)(4)) - sold in us.· biolox delta femoral head (product code: 5010.42.403, lot.7011759464) - sold in us.· delta cup - neutral liner (product code:5885.54.262, lot.2105704 - ster.(b)(4)) - not sold in us.· delta tt acetabular cup (product code: 555215620, lot.2102953 - ster.(b)(4)) - sold in us.Event occurred in italy.

• Brand Name: MINIMA S
• Common Device Name: MINIMA S FEMORAL STEM #8
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova, udine 33038
• MDR Report Key: 21091074
• Report Number: 3008021110-2024-00108
• Device Sequence Number: 15729732
• Product Code: LPH
• UDI-Device Identifier: 08033390079099
• UDI-Public: 08033390079099
• Combination Product (Y/N): N
• PMA/510(K) Number: K141327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: UNCEMENTED STEM
• Device Catalogue Number: 4503.21.080
• Device Lot Number: 2306913
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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