MAUDE Adverse Event Report: LIMACORPORATE S.P.A REVISION HIP; NECK REAMER

Catalog Number	9038.10.620
Medical Device Problem Codes	Mechanical Problem (1384); Dull, Blunt (2407)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Malfunction
Event or Problem Description
During hip revision surgery performed on (b)(6) 2026 while utilizing the revision - neck reamer (product code 9038.10.620, lot number not provided), the surgeon was unable to sufficiently ream as intended without putting significant force through the reamer and clearing out the surrounding bone with larger stem reamers due to how blunt the instrument was.Prolonged surgical time (15-30 min) and surgeon had to apply a significant amount of pressure/force to utilize the item which could have resulted in fracture as well as use alternative instruments to achieve the desired result.Patient is female, 69 years old.Event happened in australia.
Additional Manufacturer Narrative
We will submit a final mdr when the investigation is complete.

• Brand Name: REVISION HIP
• Common Device Name: NECK REAMER
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24108818
• Report Number: 3008021110-2026-00076
• Device Sequence Number: 5816082
• Product Code: LZO
• UDI-Device Identifier: 08033390112635
• UDI-Public: 08033390112635
• 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

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 Catalogue Number: 9038.10.620
• Device Lot Number: 9038.10.620
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 05/12/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown