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

Model Number 9043.10.360

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

During a revision surgery of a hip implant performed on (b)(6) 2022 (registered as complaint#: (b)(4) and reported to the fda by mfr 3008021110-2022-00063), it was impossible to remove the modulus neck l taper b 12/14 (product code: 7595.15.040, lot#: 1209333 - ster.1200246) using the modulus-strumento-estrattore (product code: 9043.10.360, lot#: 0904786).It was reported that while the handle was turned the thread of the extractor broke from the root when adding further force.According to the received information, it was impossible to remove the broken part of thread from the neck's screw, therefore a second neck extractor couldn't be used.The neck and stem were firmly attached to bone and couldn't be remove.After wound closure, post-operative x-ray showed that the distal part of the stem was protruding out of the medullary cavity.The wound was reopened, and the surgeon managed to remove the neck and the stem.Plate and wire were placed in, and a second revision surgery is going to be performed as soon as bone has grown.It was reported that surgery got prolonged by 9 hours due to the issue.The number of uses of the instrument is not known.Patient is a female.Event happened in japan.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot#: 0904786 and # 1209333, no pre-existing anomaly was found on the components manufactured with the same lot# s.We will submit a final mdr as soon as the investigation is completed.

Manufacturer Narrative

Investigation: checking the manufacturing charts of the involved lot number 0904786, no pre-existing anomaly was found on the components manufactured with the same lot number.Checking the manufacturing charts of the involved lot number 1209333, no pre-existing anomaly was found on the components manufactured with the same lot number.According to our records, at least 25 out of 30 modulus necks l taper b 12/14 with lot number 1209333 and sterilization number 1200246 have been implanted and this is the first and only complaint received on the lot number 1209333.Components analysis: the instrument was received for further analysis.The internal inspection confirmed that the instrument got broken based on the thread.We didn't receive the broken part of the thread.According to the information received by the complaint source, the modulus modular stem ø21 mm (product code 4310.15.090, lot number 1114359) implanted during the previous surgery performed on (b)(6) 2012, was cemented; this is an off-label use, because the stem is intended to be used cementless.In addition, the explanted components were returned for the internal analysis.The femoral neck was confirmed to be stuck on the femoral stem, and it couldn't be disengaged using the suitable instruments.The items were cut to inspect their internal surfaces.The analysis revealed that no cement is present in between the two contacting surfaces (the internal surface of the femoral neck and the external surface of the femoral stem taper).Fretting is found in between the surfaces, and this could have contributed to the difficulty in disengaging the two modular components.In conclusion: no pre-existing anomaly was found on the lot number 0904786.Moreover, it should be considered that the instrument was manufactured in 2009.Even if the number of uses is unknown, the instrument has been on the market for more than 10 years.As per the analysis described above, we can suppose that the breakage of the instrument is due to the extraction of the neck coupled with a cemented stem.Indeed, the instrument is intended for the extraction of the components implanted cementless, as per intended use.In addition, the fretting found could have contributed to difficulty in the neck removal.We can conclude that the issue was not product related.Pms data according to limacorporate pms data, for the instrument modulus-strumento-estrattore we estimate an occurrence rate of breakage of the thread to be 1.52 %.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 manufactured.No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final report.

Event Description

During a revision surgery of a hip implant performed on (b)(6) 2022 (registered as complaint #(b)(4) and reported to the fda by mfr 3008021110-2022-00063), it was impossible to remove the modulus neck l taper b 12/14 (product code 7595.15.040, lot number 1209333 - sterilization number 1200246) using the modulus-strumento-estrattore (product code 9043.10.360, lot number 0904786).It was reported that while the handle was turned the thread of the extractor broke from the root when adding further force.According to the received information, it was impossible to remove the broken part of thread from the neck's screw, therefore a second neck extractor couldn't be used.The neck and stem were firmly attached to bone and couldn't be remove.After wound closure, post-operative x-ray showed that the distal part of the stem was protruding out of the medullary cavity.The wound was reopened, and the surgeon managed to remove the neck and the stem.Plate and wire were placed in, and a second revision surgery is going to be performed as soon as bone has grown.It was reported that surgery got prolonged by 9 hours due to the issue.The number of uses of the instrument is not known.It was reported that the surgeon followed the surgical technique.Patient is a female.Event happened in japan.

• Brand Name: MODULUS-STRUMENTO-ESTRATTORE
• Type of Device: MODULUS - INSTRUMENTS - NECK EXTRACTOR
• 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: 15189878
• MDR Text Key: 304968248
• Report Number: 3008021110-2022-00064
• Device Sequence Number: 1
• Product Code: JDI
• 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: 02/03/2023

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: 9043.10.360
• Device Lot Number: 0904786
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2023
• 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