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

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.

• Brand Name: UNKNOWN SHELL SECUR-FIT
• Type of Device: HIP 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 Key: 8065196
• MDR Text Key: 126971645
• Report Number: 0002249697-2018-03705
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR