MAUDE Adverse Event Report: IMPLANTCAST GMBH IC-BIPOLAR HEAD; IC-BIPOLAR HEAD COCRMO Ø28/52MM

Model Number 21510052

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

An optical examination could not be performed yet, as neither an explant is available, nor a picture of the explants was provided to this day.The manufacturing documents and material certificates were checked as well as the surgical technique and the instruction for use and no deviations were found.On the provided x-ray pictures can be seen that the femoral head and the ic-bipolar head were still connected after the dislocation from the hip.This supports the description that the disconnection occurred during the reduction.No hints for a wrong indication were found.Based on the available information, no technical root cause can currently be determined of how the dislocation of the ic-bipolar head from the hip occurred.For the error pattern "dislocation / instability", the calculated occurrence rate is 0,02% and thus below the value of 3,0% accepted in risk management.

Event Description

The following event was reported to implantcast gmbh: "the patient complained of pain after surgery and visited the hospital.Surgeon checked and found that the bipolar head was dislocated.So surgeon tried to reduce and then head and cup were separated.".

Manufacturer Narrative

The optical examination revealed strong deformations on the outer and inner side on the opposite side of the safety rings opening of the ic-bipolar head.The shape of the deformations matches the geometry of the neck of the implanted hip stem.Such deformations can only occur when the neck of the hip stem is pressed against the pe-material by applying a strong leverage.The manufacturing documents and material certificates were checked as well as the surgical technique and the instruction for use and no deviations were found.On the provided x-ray pictures can be seen that the femoral head and the ic-bipolar head were still connected after the dislocation from the hip.This supports the description that the disconnection occurred during the reduction.No hints for a wrong indication were found.Based on the available information, no technical root cause could be determined of how the dislocation of the ic-bipolar head from the hip occurred.But, considering that the implantation time with less than two weeks was rather small, it is possible that the range of motion reached was too much for this implantation stadium as the support from the surrounding musculature had not sufficiently recovered at his point.Regarding the disconnection of the products, there are currently two hypotheses, which may have led to the causative strong leverage effect causing the damage on the parts: 1.Due to the hip dislocation, the bipolar head broke out of the joint capsule, so that the tissue of the joint capsule was also damaged.While the bipolar head was shoved through the damaged joint capsule, the tissue was initially pushed apart.After the bipolar head had fully emerged from the joint capsule, the tissue could have consolidated below.This would have created a "button-hole" that prevented the bipolar head from re-entering the joint capsule during closed reduction and may have created a levering effect.2.The ic-bipolar head hit the pelvic bone during the closed reduction attempt and became blocked, which in turn may also have led to the said leverage effect.

Event Description

The following event was reported to implantcast gmbh: "the patient complained of pain after surgery and visited the hospital.Surgeon checked and found that the bipolar head was dislocated.So surgeon tried to reduce and then head and cup were separated.''.

• Brand Name: IC-BIPOLAR HEAD
• Type of Device: IC-BIPOLAR HEAD COCRMO Ø28/52MM
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• Manufacturer Contact: frank ansorge ; lueneburger schanze 26; buxtehude, lower saxony 21614 ; GM 21614
• MDR Report Key: 17009713
• MDR Text Key: 316005283
• Report Number: 3012523063-2023-00006
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K191569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 21510052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ECOFIT® HIP STEM 133° CEMENTLESS STD SZ. 10MM CPTI.; ECOFIT® HIP STEM 133° CEMENTLESS STD SZ. 10MM CPTI.; IC-BIPOLAR HEAD COCRMO Ø28/52MM; IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø28MM, L.; IC-HEAD BIOLOX® FORTE TAPER 12/14MM Ø28MM, L.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male