MAUDE Adverse Event Report: LIMACORPORATE S.P.A REVISION FEMORAL STEM; REVISION NECK H. 70MM

Model Number	7515.15.020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since lot number is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family revision modular necks, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 to revise hip prosthesis.Patient was reported to be very short and surgery was needed to add length to the prosthetic assembly.Previous surgery is unknown, as well as complete information of original implant.During revision the surgeon removed the pre-existing revision modular neck h70mm (part number 7515.15.020), the femoral modular head xl dia28mm (part number 5010.09.284) and the mobile liner int dia28mm dia48mm (part number 5566.50.420) in order to implant a longer neck (revision modular neck h90mm, part number 7515.15.040) and new modular head and liner of the same size.Surgery was completed as intended.Patient is female, date of birth (b)(6) 1942.The event occurred in the united states.

• Brand Name: REVISION FEMORAL STEM
• Common Device Name: REVISION NECK H. 70MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 24176871
• Report Number: 3008021110-2026-00049
• Device Sequence Number: 21336272
• Product Code: LPH
• UDI-Device Identifier: 08033390017756
• UDI-Public: 8033390017756
• 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
• Report Date (Section B): 01/26/2026

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: 7515.15.020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• 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