MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVISION; UNCEMENTED STEM DIA=14MM - L=200MM

Model Number	REVISION HIP - TI6AL4V
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint source reported that during surgery, upon opening the package of revision mod.Stem ø14mm (product code: 3810.15.020, lot: 2413607 - ster: 2400154), they found the cellophane already unsealed.Additionally, the first sterile pouch appeared tampered with, even though the outer box looked intact and showed no signs of damage.As a result, they did not feel confident using the product and had to switch to the next size.Event occurred in italy.
Additional Manufacturer Narrative
The review of dhrs (device history records) did not highlight any pre-existing anomalies.This is the first and only complaint received on the involved lot number.A final report will be submitted after the investigation is completed.

• Brand Name: REVISION
• Common Device Name: UNCEMENTED STEM DIA=14MM - L=200MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24763576
• Report Number: 3008021110-2026-00179
• Device Sequence Number: 9267441
• Product Code: LZO
• UDI-Device Identifier: 08033390003858
• UDI-Public: 08033390003858
• 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
• Report Date (Section B): 04/01/2026

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: 3810.15.020
• Device Lot Number: 2413607
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/02/2026
• 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