MAUDE Adverse Event Report: LIMACORPORATE S.P.A. FEMORAL MODULAR HEAD - M Ø32MM; BIOLOX DELTA HEAD 32MM #M

Model Number 5010.42.322

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problem Unspecified Infection (1930)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Hip revision surgery performed on (b)(6) 2021, due to infection.It was reported that the acetabulum had a fracture.According to the complaint source, absorption occurred due to infection and the cemented cup (from a different manufacturer) migrated towards the center.It was reported that in the original plan, only neck, head and cup were going to be removed.However, the stem was removed together with the neck due to an intra-operative issue occurred during surgery.That event was registered as complaint # (b)(4) and reported to the fda with mfr 3008021110-2021-00064.During the revision, the following components were explanted: modulus modular stem ø22 mm (product code 4310.15.100, lot #1901684 - ster.1900123).Femoral modular head - m ø32mm (product code 5010.42.322, lot #1980986 - ster.1900368).Modulus neck l taper b 12/14 (product code 7590.15.040, lot #1915537 - ster.1900410) the cup was explanted as well (different manufacturer).A modulus r modular stem (product code 4330.15.220), a modulus standard neck l taper b (product code 7595.15.040), a ceramic head d.32mm (product code 5010.42.322), a protruded acetabular cup d.46mm (product code 5622.50.015), and a long acetabular plate d.50mm (product code 7660.28.110), and a reconstruction plate (from a different manufacturer) were implanted.The surgeon was reported to be satisfied with the final implant.According to the complaint source, the pathogen responsible for the infection is not known.Previous surgery on took place on (b)(6) 2020.Patient is a female, (b)(6) years old.Event happened in (b)(6).

Event Description

Hip revision surgery performed on (b)(6) 2021, due to infection.According to the complaint source, the pathogen responsible for the infection is not known.It was reported that the acetabulum had a fracture.According to the complaint source, absorption occurred due to infection and the cemented cup (from a different manufacturer) migrated towards the center.It was reported that in the original plan, only femoral neck, femoral head and acetabular cup were going to be removed.However, the stem was removed together with the neck due to an intra-operative issue occurred during surgery (intra-operative event was registered as (b)(4) and reported to the fda with mfr 3008021110-2021-00064).During the revision surgery, the following components were explanted: femoral modular head - m ø32mm (product code 5010.42.322, lot #1980986 - ster.1900368).Modulus modular stem ø22 mm (product code 4310.15.100, lot #1901684 - ster.1900123).Modulus neck l taper b 12/14 (product code 7590.15.040, lot #1915537 - ster.1900410).The acetabular cup was explanted as well.A modulus r modular stem (product code 4330.15.220), a modulus standard neck l taper b (product code 7595.15.040), a ceramic head d.32mm (product code 5010.42.322), a protruded acetabular cup d.46mm (product code 5622.50.015), and a long acetabular plate d.50mm (product code 7660.28.110), and a reconstruction plate (from a different manufacturer) were implanted.Surgeon satisfied with the final implant.Previous surgery on took place on (b)(6) 2020.Patient is a female, 79 years old.Event happened in japan.

Manufacturer Narrative

By checking the sterilization charts of the involved lot numbers, no pre-existing anomaly was found on the overall components placed on the market with the same lot numbers.No explants available to be sent back for further analysis.A single pre-operative x-ray (exact date unknown) + a single x-ray from november 2019 was received from the complaint source and analyzed by lima hip medical consultant with the following assessment: "on the pre-op x-ray a fracture is visible only at the acetabular floor, without major dislocation.This is not unusual in case of cup-loosening and should not represent a major issue in case of a revision.It might be possible, that fracture already has occurred during the primary implantation, but verification would require another x-ray of 2020*.Futhermore the x-ray also shows lucent lines around neck and stem.Removal of the stem together with the neck not surprisingly should also be manageable without major difficulties.I therefore do not understand, why additional plating was necessary.It is unclear how the issue of infection has been addressed.When infected complete removal of implants is mandatory.The 2019 x-ray shows a perfectly implanted uncemented thr, no sign of loosening.Since there is no failure technically in 2019 only reason for revision can be infection already at the respective revision".Complaint source reported that wall behind the acetabulum was cracked due to a not specified impact.Infection was managed by administering antibiotic continuously.The revision for infection was performed in a single-stage procedure.Unfortunately, pre-op x-rays from 2020 were not available.Based on the info provided and analyzed, we cannot investigate further about this case.According to the dhr review and medical consultant assessment, this case is not product related.Pms data: (b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: FEMORAL MODULAR HEAD - M Ø32MM
• Type of Device: BIOLOX DELTA HEAD 32MM #M
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12370023
• MDR Text Key: 268664430
• Report Number: 3008021110-2021-00068
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K141327
• 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: 11/22/2021

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: 5010.42.322
• Device Catalogue Number: 5010.42.322
• Device Lot Number: 1980986
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other