MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=20MM - L=200MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2025
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 1308341.This is the first and only complaint received regarding this lot number 1308341.A final report will be submitted at the conclusion of the investigation.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to breakage of the revision hip - uncemented stem d.20 mm l.200 mm (product code: 3816.15.020 - lot: 1308341).Together with the stem the revision neck (7515.15.010) was also explained (lot number unknown).The event occurred in switzerland.
Additional Manufacturer Narrative
The device history records of the lot number involved were checked and no pre-existing anomaly was detected on the items manufactured with lima lot number: 1308341.This is the first and only complaint recorded on this lot number.The explanted stem was received for analysis.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.Based on the very few available information, we cannot determine with certainty the cause of the reported breakage, however, considering the absence of pre-existing anomalies by the check of the device history records and the visual inspection of the retrieved devices, we believe that the breakage occurred due to fretting started mechanism.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.This is a final mdr report.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to breakage of the revision hip - uncemented stem d.20 mm l.200 mm (product code: 3816.15.020 - lot: 1308341).Together with the stem the revision neck (7515.15.010) was also explained (lot number unknown).The event occurred in switzerland.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=20MM - L=200MM
• 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: 22051068
• Report Number: 3008021110-2025-00069
• Device Sequence Number: 12988781
• Product Code: LZO
• UDI-Device Identifier: 08033390003919
• UDI-Public: 08033390003919
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/04/2025

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: REVISION HIP - TI6AL4V
• Device Catalogue Number: 3816.15.020
• Device Lot Number: 1308341
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/04/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown