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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUZHIOU 26MM -3MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER SUZHIOU 26MM -3MM V40 TRIAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6264-8-026
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2018
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
After leaving the hospital, it was reported that the v40 head trial remained in the patient.It is believed that credibility is high because x - ray does not have such shadows and instrument points.Due to the risk of fracture at the time of intraoperative, cup trial was not worn, temporary reduction with rasp, neck, head trial.The implant also entered successfully, so it seems that the trial head is in the joint capsule.Events and considerations occurred because it was not confirmed that the trial head was removed at trial and that the instruments was not returned to the instrument table.
 
Event Description
After leaving the hospital, it was reported that the v40 head trial remained in the patient.It is believed that credibility is high because x - ray does not have such shadows and instrument points.Due to the risk of fracture at the time of intraoperative, cup trial was not worn, temporary reduction with rasp, neck, head trial.The implant also entered successfully, so it seems that the trial head is in the joint capsule.Events and considerations occurred because it was not confirmed that the trial head was removed at trial and that the instruments was not returned to the instrument table.
 
Manufacturer Narrative
An event regarding off label use involving a partnership trial head was reported.It was identified that a partnership trial head was left implanted during surgery.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.A review of ifu qin (b)(4) revision ab, noted the following: utilization howmedica osteonics trial components should be used for size determination, preparation evaluation, trial reduction and range of motion evaluation, thus helping to preserve the integrity of the actual implants and their sterile packaging.A review of the trident acetabular system psl surgical protocol, triden-sp-3_rev-2_14606, noted the following: step 8: head assembly prior to head assembly, neck length selection may be re-evaluated using a stryker v40 or c-taper trial head.Place the trial head onto the stem neck taper and reduce the hip to verify that the mechanics have not been altered due to implant seating.Remove the trial head and dry the implant trunnion with a laparotomy sponge or sterile towel.Select the appropriate corresponding v40 or c-taper femoral head size and place it onto the dry trunnion of the femoral stem with a slight twist.Impact the head with two moderate blows using the stem head impactor ((b)(4)).No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
26MM -3MM V40 TRIAL HEAD
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER SUZHIOU
no. 18 wuxiang, epz zone a
200 suhong road, sip
suzhou NJ 21502 1
CN  215021
MDR Report Key7309784
MDR Text Key101412302
Report Number0002249697-2018-00616
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K161569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6264-8-026
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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