MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TRIAL NECK WITH SCREW H=60MM; TRIAL NECK H60 WITH SCREW

Model Number 9038.10.660

Device Problem Entrapment of Device (1212)

Patient Problem Failure of Implant (1924)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing charts of lot #19bg01z, no anomalies were detected on the products manufactured with the same lot #.By checking the manufacturing charts of lot #2020621, no anomalies were detected on the products manufactured with the same lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During hip surgery performed on (b)(6) 2021, the trial neck with screw h=60mm (product code 9038.10.660, lot# 19bg01z) got stuck into the revision modular stem ø21mm (product code 3817.15.020, lot# 2020621).Consequently, during the reduction the bone was fractured.Event happened in (b)(6).

Manufacturer Narrative

Investigation: by checking the manufacturing charts of lot 19bg01z, no anomalies were detected on the products manufactured with the same lot number.By checking the manufacturing charts of lot 2020621, no anomalies were detected on the products manufactured with the same lot number.Components analysis: the instrument and the stem involved in the complaint were returned to limacorporate for further analysis.We performed an internal analysis, trying to replicate the problem described in the complaint.The functional tests highlighted that the trial neck with screw h=60mm screwed and unscrewed correctly on the revision modular stem ø21mm.The same test was done using another trial neck, and no anomaly was found.The dimensional check performed on both the instrument (neck and screw) and the stem highlighted no anomalies.Checking the thread of the screw, it doesn't show any damage.Based on the analysis performed, we can suppose that the seizure between the components could have been caused by the presence of tissue or debris.In conclusion: checking the manufacturing charts of the two lot numbers involved, no anomalies were found.The internal analysis and tests performed didn't show any malfunction or damage.Therefore, we can suppose that the problem experienced was not product related.Pms data: according to our pms data, we can estimate the malfunctioning occurrence rate of the instrument trial neck with screw to be about 0,01% worldwide.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 manufactured.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.

Event Description

During hip surgery performed on (b)(6) 2021, the trial neck with screw h=60mm (product code 9038.10.660, lot number 19bg01z) got stuck into the revision modular stem ø21mm (product code 3817.15.020, lot number 2020621).Consequently, during the reduction the bone was fractured.The surgery was concluded using a revision lr stem.The patient is a female, 83 years old.Event happened in italy.

• Brand Name: TRIAL NECK WITH SCREW H=60MM
• Type of Device: TRIAL NECK H60 WITH SCREW
• 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: 11862309
• MDR Text Key: 255140801
• Report Number: 3008021110-2021-00040
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K151739
• 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: 04/04/2023

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: 9038.10.660
• Device Lot Number: 19BG01Z
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other