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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SHELL SECUR-FIT HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SHELL SECUR-FIT HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Malposition of Device (2616); Positioning Problem (3009)
Patient Problems Edema (1820); Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative
An event regarding altr involving an unknown secur-fit shell was reported. Rom and shell malposition was confirmed following a clinician review, altr could not be confirmed. Method & results: device evaluation and results: not performed as the device remains implanted. Medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: complex malposition of components with low inclination/high anteversion of the cup shell in combination with non appropriate use of an asymmetric liner and low implantation position of the accolade stem requiring an extra-long skirted femoral head in a previous pelvic fracture deformity contributed in concert to a high risk on impingement, evident in the mar, contributing to overload in the bearing with secondary corrosion and altr causing pain and requiring revision. Does the review identify any procedural related factors that contributed to the event? cup malposition in low effective inclination and high anteversion inappropriate use of an asymmetric liner. Low implantation position of the stem requiring a skirted femoral head for compensation with increased risk on impingement as side effect. Does the review identify any patient related factors that contributed to the event? prior pelvic deformity due to trauma no information about potential overweight condition of the patient. Device history review could not be performed as the device lot is unknown. Complaint history review could not be performed as the device lot is unknown. Conclusion: a review by a clinical consultant concluded: complex malposition of components with low inclination/high anteversion of the cup shell in combination with non appropriate use of an asymmetric liner and low implantation position of the accolade stem requiring an extra-long skirted femoral head in a previous pelvic fracture deformity contributed in concert to a high risk on impingement, evident in the mar. Additional information, including device details, return of the device, operative reports, histopathology reports, progress notes and mri scan are needed to fully investigate the event. If further information becomes available this investigation will be re-opened. Not returned to the manufacturer.
 
Event Description
Female patient underwent a revision hip surgery. The initial reason for revision was soft tissue reaction to particulate debris. Upon initial incision into the patient¿s capsule a copious amount (2 liters or more) of a muddy brown fluid was release onto the drapes. The hip was debrided and irrigated. The head was removed using 3-4 taps of a bone tamp. The surgeon elected to remove the accolade i stem and replace it with an exactech stem. The surgeon elected to keep the shell in place and replace the worn liner. From "how was the issue noticed": the patient came in complaining of pain. A ct scan was done which showed fluid accumulation around the hip joint. Update 16 oct 18: a review by a clinical consultant has identified an unknown shell (possibly secur-fit shell) and stem in malposition.
 
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Brand NameUNKNOWN SHELL SECUR-FIT
Type of DeviceHIP IMPLANT
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
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8065196
MDR Text Key126971645
Report Number0002249697-2018-03705
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
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