MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BEATER - POSITIONER - ALIGNER

Model Number 9057.20.555

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #20aroew and #2014375 no pre-existing anomalies were found.Of the 12 total components in this manufactured with this lot# 20aroew.This is the first and only complaint received on this lot #.We will send final report after the investigation is complete.

Event Description

During hip surgery performed on (b)(6) 2023, the cup impactor instrument failed, and the cup wouldn't loosen off the impactor.The instrument has been used for 500 times approximatively.There was a small delay in surgery time(unknown) to obtain replacement instrument and cup.Surgery was completed successfully.Instrument id: beater - positioner - aligner, commercial code 905720555 - lot #20ar0ew.Delta tt pro cup d.56mm large+, commercial code 555314564 - lot #2014375 - ster.#2000294.

Manufacturer Narrative

Investigation checking the manufacturing charts of the involved lot number 20ar0ew no pre-existing anomalies were found.Likewise, no pre-existing anomalies were found out on the (b)(4) pieces belonging to the lot number 2014375 and sterilization 2000294, checking the manufacturing charts.According to our records, all the (b)(4) items belonging to the lot number 2014375 and sterilization 2000294 have been implanted.This is the first and only complaint received on the lot numbers above mentioned.Instrument analysis the instrument and the implantable device have been returned for further analysis.Firstly, the instrument has been disassembled from the cup, as they have been returned still assembled.Then the instrument and the cup have been measured, without finding any anomaly.According to the surgical technique, the beater - positioner - aligner should be used in the introduction of the trial cup.The trial cup should be assembled onto the beater - positioner - aligner (or alternatively onto the multipurpose handle) and then placed in the acetabulum in an anatomic orientation.At this point, the definitive cup having the same nominal diameter as that of the trial cup used, should be impacted in the acetabulum.The surgeon has to choose the adaptor size according to the cup size and assemble the adaptor and the cup on the end of the wrench for delta cup (commercial code 9055.51.015).In this specific case, the beater - positioner - aligner has been used to impact the definitive cup, therefore the instrument has been used off-label.In conclusion, considering that: - the check of the manufacturing charts did not highlight any pre-existing anomaly - the measurements of the instrument and the cup are compliant with the specifications.- based on the information received by the complaint source, the instrument has been used off-label.We can state that the event was not product related.Pms data according to the pms data, the occurrence rate of similar events involving the beater - positioner - aligner is around (b)(4).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.Note: this is a final mdr.

Event Description

During hip surgery performed on (b)(6) 2023, the cup impactor instrument failed, and the cup did not loosen off the impactor.The instrument has been used for 500 times approximatively.There was a small delay in surgery time (unknown) to obtain replacement instrument and cup.Surgery was completed successfully.The instrument involved in the complaint is the following: beater - positioner - aligner, commercial code 9057.20.555 - lot number 20ar0ew.The instrument has been used with the following cup: delta tt pro cup d.56mm large+, commercial code 5553.14.564 - lot number 2014375 - sterilization 2000294.Event happened in the united states.

• Brand Name: BEATER - POSITIONER - ALIGNER
• Type of Device: BEATER - POSITIONER - ALIGNER
• 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: 17377865
• MDR Text Key: 320609832
• Report Number: 3008021110-2023-00079
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: 9057.20.555
• Device Lot Number: 20AR0EW
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other