MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=14MM - L=140MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a revision hip stem surgery, it was reported that the surgeon had to change the implant because the diameter indicated on the initial revision mod.Stem ø14mm (code: 3810.15.010, lot: 2308645 - ster: (b)(4)) was too small (not the correct diameter) and did not fit in the femur.To complete the surgery the surgeon had to implant another hip stem - revision mod.Stem ø16mm (code: 381215010, lot: 2323150 - ster.(b)(4)) - with a diameter of 16 mm and a length of 140 mm instead of a hip stem with a diameter of 14 mm and a length of 140 mm, as originally planned.It was reported that there was a 10-minute delay on the surgery.Event occurred in france.
Additional Manufacturer Narrative
According to our dhrs no pre-existing anomalies were detected on the involved lot: 2308645.This is the first and only complaint received on the reported lot number 2308645.A final report will be submitted after the completion of the investigation.
Event or Problem Description
During a revision hip stem surgery, it was reported that the surgeon had to change the implant because the diameter indicated on the initial revision mod.Stem ø14mm (code: 3810.15.010, lot: 2308645 - ster: 2300148) was too small (not the correct diameter) and did not fit in the femur.To complete the surgery the surgeon had to implant another hip stem - revision mod.Stem ø16mm (code: 381215010, lot: 2323150 - ster.2300246) - with a diameter of 16 mm and a length of 140 mm instead of a hip stem with a diameter of 14 mm and a length of 140 mm, as originally planned.It was reported that there was a 10-minute delay on the surgery.Event occurred in france.
Additional Manufacturer Narrative
According to our dhrs no pre-existing anomalies were detected on the involved lot: 2323150 - ster.2300246.Based on our data at least 11 pieces out of 20 pieces manufactured with lot number lot: 2323150 - ster.2300246, have been implanted and this is the first and only complaint received regarding this lot number.The device was returned to limacorporate for investigation.Dimensional analysis performed on the returned component confirmed that all measurements were within the specifications outlined in the reference drawing.Therefore, the reported issue could not be confirmed, as the product was found to be compliant with design requirements.It is hypothesized that the issue may have resulted from intra-operative over-reaming by the operator; however, this assumption cannot be conclusively verified.Pms data: according to pms the occurrence rate of similar complaints - intra-operative issue due to dimensional anomalies of stem - is nearly 0.004%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr report.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=14MM - 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, 30038
• MDR Report Key: 21960316
• Report Number: 3008021110-2025-00056
• Device Sequence Number: 9253343
• Product Code: KWY
• UDI-Device Identifier: 08033390003841
• UDI-Public: 08033390003841
• Combination Product (Y/N): N
• PMA/510(K) Number: K151739
• 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,Followup
• Report Date (Section B): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: REVISION HIP - TI6AL4V
• Device Catalogue Number: 3810.15.010
• Device Lot Number: 2308645
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown