MAUDE Adverse Event Report: LIMACORPORATE S.P.A REVISION FEMORAL STEM; REVISION NECK H. 90MM

Model Number	7515.15.040
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records of all explanted components did not identify any pre-existing anomaly or non-conformity that could have caused reported issue, therefore a native product problem can be excluded.Complaint database review revealed no further cases reported for involved batches from the market.Explanted components have been discarded therefore cannot be returned to manufacturer for analysis.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.Based on all gathered information, the manufacturer has no evidence to consider the event as product related, however precise root cause cannot be established.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 due to dislocation of hip prosthesis.Previous surgery occurred on (b)(6) 2025 and traced in another complaint (reported as mfr.3008021110-2026-00049).Patient dislocated the hip prosthesis consisting of: revision modular neck h.90mm (part number 7515.15.040, lot 2124174, sterilization (b)(4), mobile liner øint 28 mm ø42 mm (part number 5566.50.420, lot 25at0x1, sterilization (b)(4), fem.Modular head - xl ø28mm (part number 5010.09.284, lot 2436599, sterilization (b)(4).The revision neck was replaced with another one and the liner was removed to implant a costrained liner from another manufacturer.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. 90MM
• 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: 24176873
• Report Number: 3008021110-2026-00112
• Device Sequence Number: 13266020
• Product Code: LPH
• UDI-Device Identifier: 08033390017770
• UDI-Public: 8033390017770
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 7515.15.040
• Device Lot Number: 2124174
• 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