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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANTCAST GMBH IC-BIPOLAR HEAD; IC-BIPOLAR HEAD COCRMO Ø 28/53MM
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IMPLANTCAST GMBH IC-BIPOLAR HEAD; IC-BIPOLAR HEAD COCRMO Ø 28/53MM Back to Search Results
Model Number 21510053
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 11/16/2022
Event Type  Injury  
Event Description
The femoral head was dislocated one week after primary surgery.The surgeon explained that the dislocation happened during reduction.The safety ring remains as before.He therefore does not understand how the femoral head dislocates even though it is closed by the safety ring.
 
Manufacturer Narrative
On 17.11.2022 implant cast gmbh was informed about the dislocation of an ic-bipolar head cocrmo.An optical examination could not be performed as neither an explant is available, nor a picture of the explants was provided.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 both femoral heads were still connected after the dislocation from the hip.It is assumed the disconnection of both femoral heads occurred after the dislocation, due to the attempt of a closed repositioning from the attending surgeon.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.
 
Event Description
The femoral head was dislocated one week after primary surgery.The surgeon explained that the dislocation happened during reduction.The safety ring remains as before.He therefore does not understand how the femoral head dislocates even though it is closed by the safety ring.
 
Manufacturer Narrative
On 17.11.2022 implantcast gmbh was informed about the dislocation of an ic-bipolar head cocrmo.The ic-bipolar head and the ic-head biolox® delta taper are both available for an optical examination.The ic-bipolar head shows some scratches on the spherical part.It is assumed that these scratches occurred after the dislocation.Furthermore, the pe-inlay was deformed.Probably the pe-inlay was deformed when both femoral heads disconnected from each other during the attempt of a closed reposition.The ic-head biolox® delta taper has several scratches, especially in the connecting part to the stem.It is assumed that the scratches were occurred during implantation or explantation.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 both femoral heads were still connected after the dislocation from the hip (see figure 5).It is assumed the disconnection of both femoral heads occurred after the dislocation, due to the attempt of a closed repositioning from the attending surgeon.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.However, it is noticeable that all cases subject to reporting to the authorities with this error pattern were reported from korea, hence it is assumed that this might be a korean specific problem.With regards 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, the dislocation may occur.With only 1 week 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.
 
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Brand Name
IC-BIPOLAR HEAD
Type of Device
IC-BIPOLAR HEAD COCRMO Ø 28/53MM
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
frank ansorge
lueneburger schanze 26
buxtehude, 21614
GM   21614
MDR Report Key15994671
MDR Text Key305585321
Report Number3012523063-2022-00004
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K191569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number21510053
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ECOFIT® HIP STEM 133° REF:30373125 LOT:220723K024; ECOFIT® HIP STEM 133° REF:30373125 LOT:220723K024; IC-HEAD BIOLOX® DELTA REF 25862805 LOT 22-3220874; IC-HEAD BIOLOX® DELTA REF 25862805 LOT 22-3220874
Patient Outcome(s) Required Intervention;
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