MAUDE Adverse Event Report: IMPLANTCAST GMBH IC-BIPOLAR HEAD COCRMO; IC-BIPOLAR HEAD COCRMO Ø 28/51MM

Model Number 21510051

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Remark implantcast (b)(4): please be aware of the difference between the terms dislocation and disconnection that were used by implantcast (b)(4) in this report.Dislocation: due to the design of the bi-polar head it is possible that the whole system (the bi-polar head and the femoral head) can dislocate out of the natural acetabulum as a whole.Disconnection: it is also possible that the individual components of this system disconnect, resulting in a separation of the ic-bipolar head and the femoral head.During the optical inspection a deformation of the safety ring was detected.The metal shell did not show any significant signs of wear.This leads to the assumption that the stems neck collided with the safety ring and may have levered the head out of the ic-bipolar head causing the disconnection.The manufacturing protocols as well as the information material did not show any signs of failure or incompleteness.However, the instructions for use lists a dislocation as possible adverse event.For the evaluation of the x-ray images, implantcast (b)(4) contacted a physician, who is experienced with this system.According to him there is an implantation error that may have caused the dislocation of the ic-bipolar head.The used combination does not induce enough joint tension which increases the risk of a dislocation.However, it is also worth noting that there is a noticeable clustering of incidents from (b)(6), as all incidents reported in recent time have happened there.Leading to the assumption that there also might be a (b)(6) related problem involved.With regard to their culture it is worth mentioning, that a main way of sitting is in a tailor seat, which needs a big range of motion of the hip joint.If an attempt is made to reach this range of motion too early after implantation along with a decreased joint tension due to implantation error, dislocation may occur as well.With only about 1 month the implantation time is rather small.Therefore, regarding the case at hand it is possible, that the range of motion that was reached was too big for this implantation stadium.This assumption is also transferable to most of the other known cases with this error pattern.As to the disconnection, since it is known that in similar cases first a dislocation and afterwards a disconnection took place due to a (assumable closed) reposition that failed, we assume that this was also the fact in the present case.The consulting physician presumed a wrong repositioning of the head, which can cause the ic-bipolar head to cant and get stuck e.G.On the edge of the natural acetabulum and leads to the levering described above.So, all in all it is assumed here that at first the system dislocated and afterwards disconnected.Furthermore, it is assumed that the dislocation occurs due to implantation error and / or due to (b)(6) specific problems.

Event Description

On (b)(6) 2021 implantcast (b)(4) received the message that an ic-bipolar head dislocated and disconnected, after about 1 month of implantation time.

• Brand Name: IC-BIPOLAR HEAD COCRMO
• Type of Device: IC-BIPOLAR HEAD COCRMO Ø 28/51MM
• Manufacturer (Section D): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer (Section G): IMPLANTCAST GMBH; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• Manufacturer Contact: jens sass ; lueneburger schanze 26; buxtehude, 21614 ; GM 21614
• MDR Report Key: 12347475
• MDR Text Key: 268676687
• Report Number: 3012523063-2021-00002
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K181778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

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 Operator: No Information
• Device Model Number: 21510051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/20/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention