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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HA HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

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STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HA HIP STEM #9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Model Number 6017-0935A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 11/01/2021
Event Type  Injury  
Event Description
It was reported that after implantation of a right stryker hip and competitor knee, the patient fell and sustained a femoral fracture near the distal tip of the stem.No implants were revised, but an orif was performed with implantation of a plate and screws.Rep confirmed that no further information will be released by the hospital or surgeon.
 
Manufacturer Narrative
Reported event:: an event regarding periprosthetic fracture involving an omnifit stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection, material analysis, dimensional and functional inspections were not performed as the device remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated " this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis.The causes of dislocation a few days following hip arthroplasty are almost always iatrogenic meaning that there was most likely failure to restore the proper soft tissue tension to the thigh muscles and possibly impingement may have occurred.Without x-rays or other diagnostic tools, i cannot comment on the root cause of the dislocation with certainty.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced that relates to periprosthetic fracture for the same device/patient; therefore, no further trending is required for this commonality.Conclusions: a review of the provided medical records by a clinical consultant indicated " this patient ostensibly had a well-functioning right cementless total hip arthroplasty but then sustained a fracture of the femur below the tip of the stem.The patient already had a competitor total knee arthroplasty in place.An open reduction and internal fixation was carried out but this resulted in a nonunion with breakage of screws and pull away of the plate.The patient subsequently required a total femoral replacement and then sustained a dislocation of the hip which required insertion of a constrained liner.I can confirm that the patient had a primary right total hip arthroplasty and prior surgery with plate and screws which appears to be for a mid-shaft femoral fracture below the tip of the stem.I have only a single x-ray showing what i described.I have no documentation of further procedures regarding x-rays, office notes or operation notes.Causes of these events are multifactorial and the root causes cannot be determined with certainty.The patient did sustain a fall which resulted in a fracture of the femoral shaft below the tip of the stem.This would definitely be the cause of the fracture itself.Failure of fixation is multifactorial including surgical technique, patient bone quality issues, patient activity level and bmi.Screw breakage is not uncommon when internal fixation fails and in my opinion is not necessarily the fault of the screw but rather the technique of fixation and stability of the fracture.The cause of nonunion is also multifactorial including surgical technique, local bone factors and postoperative compliance with weight bearing, etc.I have no x-rays which would allow me to comment on the need for a total femoral prosthesis.The causes of dislocation a few days following hip arthroplasty are almost always iatrogenic meaning that there was most likely failure to restore the proper soft tissue tension to the thigh muscles and possibly impingement may have occurred.Without x-rays or other diagnostic tools, i cannot comment on the root cause of the dislocation with certainty.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
 
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Brand Name
OMNIFIT HA HIP STEM #9
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key17076308
MDR Text Key316661308
Report Number0002249697-2023-00645
Device Sequence Number1
Product Code MEH
UDI-Device Identifier07613327038279
UDI-Public07613327038279
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/06/2023
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 Health Professional
Device Expiration Date11/30/2004
Device Model Number6017-0935A
Device Catalogue Number6017-0935A
Device Lot Number46754903
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2023
Initial Date FDA Received06/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/1999
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age82 YR
Patient SexFemale
Patient Weight84 KG
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