MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=20MM - L=140MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By the checking of dhrs, no pre-existing anomalies were detected on the involved lot number 1110071.This is the first and only complaint received on this lot number.A final report will be submitted at the conclusion of the investigation.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to breakage of revision mod.Stem.(product code: 3816.15.010 - lot: 1110071 - ster.(b)(4)).It was reported no trauma.Fracture of stem conus.The previous surgery was performed on (b)(4) 2014 after fracture.The following limacorpoarate devices were all explanted: · revision mod.Stem ø20mm (product code: 3816.15.010, lot: 1110071 - ster.(b)(4)) - sold in us.· delta neutr.Liner øint 32mm #m (product code: 5885.51.158, lot: 1313238 - ster.(b)(4)).· revision later.Neck h.60mm (product code: 7515.15.110, lot: 1011926 - ster.(b)(4)).Also, a device manufactured by depuy was explanted: biolox delta ceramic femora head (depuy - code: 1365.32.320 - lot: 7838723).Patient is a male, 51 years old, approximate height 184 cm, approximate weight 100kg.Event occurred in switzerland.
Additional Manufacturer Narrative
By review of the device history records (dhrs), no pre-existing anomalies were detected for the involved lot number 1110071.This is the first and only complaint received for this lot number.The complaint source provided x-rays taken in 2025 (exact date unknown) and pictures of the explant, which were sent to a medical consultant for evaluation.His assessment is reported below: "implantation took place 2014 - fracture occurred 2025.11 years! fracture is not unusual in modular implants of that kind as the junction site is always undergoing fretting by micromotion and consecutive erosion.In this case it happened in an active and heavy young men, which even accelerates erosion." the explanted device was returned to limacorporate for further investigation.By the visual inspection, it was confirmed that the fracture occurred at the level of the stem male taper.The fracture appears compatible with a breakage due to fatigue; the visual analysis suggests that the mechanism might have started due to fretting phenomenon at the stem-neck modular junction.It should also be considered that, based on the information provided by the complaint source and the explanted devices returned to us, limacorporate devices were used in combination with devices manufactured by a different manufacturer (depuy), for which compatibility has not been proven.Therefore, the consequences of such coupling are not predictable.Based on the available information, the root cause of the reported breakage cannot be determined with certainty.However, considering the absence of pre-existing anomalies identified through the review of the device history records and the visual inspection of the retrieved devices, it is assumed that the breakage occurred due to a fretting-initiated mechanism, although the combination of limacorporate devices with those of other manufacturers may have contributed to the event.Pms data: according to limacorporate pms data, the revision rate of the revision stems due to breakage is around (b)(4).Following a corrective/preventive action performed in the past, the shot-peening process on the male tapers of revision stems was introduced in 2015 to further increase the mechanical resistance of the modular connection between the stem and the neck.The femoral stem involved in this complaint was manufactured before the introduction of the shot peening treatment on the stem male tapers.Limacorporate is not aware of any breakages involving revision stems treated with shot-peening.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to breakage of revision mod.Stem.(product code: 3816.15.010 - lot: 1110071 - ster.(b)(4)).It was reported no trauma.Fracture of stem conus.The previous surgery was performed on (b)(6) 2014 after fracture.The following limacorpoarate devices were all explanted: · revision mod.Stem ø20mm (product code: 3816.15.010, lot: 1110071 - ster.(b)(4)) - sold in us.· delta neutr.Liner øint 32mm #m (product code: 5885.51.158, lot: 1313238 - ster.(b)(4)).· revision later.Neck h.60mm (product code: 7515.15.110, lot: 1011926 - ster.(b)(4)).Also, a device manufactured by depuy was explanted: biolox delta ceramic femora head (depuy - code: 1365.32.320 - lot: 7838723).Patient is a male, 51 years old, approximate height 184 cm, approximate weight 100kg.Event occurred in switzerland.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=20MM - L=140MM
• 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, 33038
• MDR Report Key: 22435545
• Report Number: 3008021110-2025-00097
• Device Sequence Number: 19621113
• Product Code: KWY
• UDI-Device Identifier: 08033390003902
• UDI-Public: 08033390003902
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: REVISION HIP - TI6AL4V
• Device Catalogue Number: 3816.15.010
• Device Lot Number: 1110071
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 01/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male