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

Model Number	9038.10.620
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a tha performed on (b)(6) 2025, the neck reamer (product code 9038.10.620, lot n.16aq0ag) was blunt in a consignment set and caused a very difficult reaming, particularly with hard bones.For this issue the surgery was delayed for more than 40 mins.Patient is 65 yeas old.Event happened in australia.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the involved lot #16aq0ag, no pre-existing anomaly was found on the 15 devices manufactured with the same lot #.We submit a final mdr when the investigation is complete.
Event or Problem Description
During a tha performed on (b)(6) 2025, the neck reamer (product code 9038.10.620 lot n.16aq0ag) was blunt in a consignment set and caused a very difficult reaming, particularly with hard bones.For this issue the surgery was delayed for more than 40 mins.Patient is 65 yeas old.Event happened in australia.
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the involved lot #16aq0ag, no pre existing anomaly was found on the 15 devices manufactured with the same lot#.The device was part of a consignment set and had been inspected prior to being dispatched to the hospital.The surgeon involved in the procedure was experienced and familiar with the surgical technique.Following delivery, the set remained stored on the hospital shelves and had been on consignment for just over nine months.During its life period, it was used approximately 30 times.Device analysis the instrument was returned to limacorporate for further analysis.Visual inspection confirmed that the component dedicated to femoral reaming for proximal neck site preparation is blunt, indicating wear over time.This wear could have led to prolonged use in the case of particularly sclerotic and hard bone, thereby extending the operative time.The neck reamer (product code 9038.10.620) is specifically designed for revision stem procedures, where the femoral canal is typically already prepared and the reaming is focused on the proximal neck zone.In such procedures, reaming on hard bone is expected, but the instructions for use recommend the use of progressive reamers and appropriate technique, avoiding excessive force on a single instrument.Considering that: check of manufacturing charts highlighted no anomalies on the instruments manufactured with lot #16aq0ag; the instrument was manufactured in 2016, serving the market for 9 years; the device had been on consignment at the facility for approximately nine months and the manufacturer could not verify its condition at the time of surgery; we cannot define with certainty the root cause of the event.We can hypothesize that unexpected stresses have been applied to the instrument, leading to overstress in the reaming zone, possibly exacerbated by repeated use and eventual wear.This condition may have been further aggravated by application of the instrument on very hard bone, requiring prolonged reaming and consequently increasing operative time and surgical difficulty.Given the above, the event is assessed as not due to a product defect or manufacturing failure, but rather to instrument wear that was not identified by the hospital facility during the consignment[?]use period.The combination of prolonged use, repeated sterilization cycles, and challenging intraoperative conditions (hard bone) led to reduced performance of the reamer, which contributed to the difficult reaming and prolonged operative time.Pms data this is the first event for product malfunctioning reported in the past 3 years among the 12 instruments supplied in australia up to surgery's date (8,33%).At worldwide level, there has been one similar event in the past three years from a total of 193 instruments supplied (corresponding to 0,52%).Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments, but only the total number of pieces supplied to the market.The instrument is a reusable device and the manufacturer has reviewed guidance for similar event calculation for reusable devices.Currently, for this product, there is no anticipated or defined number of uses per year.Furthermore, as these are non[?]implantable reusable instruments, they do not have a predetermined lifetime expressed as a fixed number of uses.Therefore, the manufacturer has concluded that the most suitable calculation method for the incident rate is number of similar events / total number of units sold × 100 over the last three years.This calculation is intended to be a conservative estimate rather than a usage[?]based rate, due to the lack of precise data on actual reuse and number of procedures per instrument.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions are required for this specific case.Limacorporate continues monitoring the market to promptly detect similar issues and to reassess the need for any further actions, including potential updates to instructions for use or reprocessing recommendations.This is a final mdr report.

• 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: 23692499
• Report Number: 3008021110-2025-00160
• Device Sequence Number: 9124038
• Product Code: LZO
• UDI-Device Identifier: 08033390112635
• UDI-Public: 08033390112635
• Combination Product (Y/N): Y
• 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 Model Number: 9038.10.620
• Device Catalogue 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: 12/02/2025
• Supplement Report FDA Received Date: 02/25/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown