MAUDE Adverse Event Report: LIMACORPORATE S.P.A MODULUS; MODULUS MODULAR STEMS (TI6AL4V) DIA 24MM TAPER B

Model Number	4310.15.120
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A second revision total hip arthroplasty (tha) was performed on (b)(6) 2026, due to loosening associated with osteolysis.During the procedure, the surgeon explanted the following devices: modulus mod.Stem ø24 mm (product code 431015120, lot #1202597 and ster.N.(b)(4), fem.Modular head - l ø32mm (product code 5010.09.323, lot #1303276 and ster.N.(b)(4), modulus neck s taper b 12/14 (product code 7590.15.030, lot #1308590 and ster.N.(b)(4).The primary surgery was performed on (b)(6) 2013 and the first revision was performed on (b)(6) 2013.Patient is male, 67 years old with high activity level.Event happened in japan and related to (b)(4).
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the involved lot #1202597 and ster.N.(b)(4), no pre-existing anomaly was found on (b)(4) devices manufactured with the same lot #.A final mdr will be shared upon completion of the investigation.

• Brand Name: MODULUS
• Common Device Name: MODULUS MODULAR STEMS (TI6AL4V) DIA 24MM TAPER B
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24377806
• Report Number: 3008021110-2026-00139
• Device Sequence Number: 14671203
• Product Code: LPH
• UDI-Device Identifier: 08033390004862
• UDI-Public: 08033390004862
• Combination Product (Y/N): Y
• PMA/510(K) Number: K112158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 4310.15.120
• Device Catalogue Number: 4310.15.120
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown