MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MODULUS-STRUM. - ESTRATTORE; NECK EXTRACTOR

Model Number 9043.10.360

Device Problems Break (1069); Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

During hip revision surgery performed on (b)(6) 2021, the surgeon tried to remove only the modulus neck l taper b 12/14 (product code 7590.15.040, lot #1915537), however he experienced difficulties in removing it.According to the complaint source, the extractor modulus-strum.- estrattore (product code 9043.10.360, lot #1401263) was stiff.In the original plan, the stem was not loosened, and was going to remain implanted.However, due to the encountered issues in removing the neck, it was reported that the surgeon decided to remove the modulus modular stem ø22 mm (product code 4310.15.100, lot #1901684) together with the neck to conclude surgery.Additionally during surgery, according to the complaint source, surgeon turned the wrench zimmer connection h210mm (product code 9095.10.131, lot #15ag0tp) with strong strength resulting in breakage at the junction between the t-handle and the extractor.It was reported that surgery was prolonged of about 2 hours.Patient is a female, (b)(6).Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot #s, no pre-existing anomaly was found on the components manufactured with the same lot #s.We will submit a final mdr once the investigation will be completed.

• Brand Name: MODULUS-STRUM. - ESTRATTORE
• Type of Device: NECK EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12370006
• MDR Text Key: 281283026
• Report Number: 3008021110-2021-00064
• Device Sequence Number: 1
• Product Code: KWY
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9043.10.360
• Device Lot Number: 1401263
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other