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

Catalog Number UNK_JR

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding dislocation involving a metal head and crossfire liner was reported.Medical review by a clinician identified malposition of the shell as a root cause of the dislocation.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: left total hip arthroplasty was performed some time in 2003 in a female patient of (b)(6) with severe obesity (bmi=39) using an accolade tmzf stem with stryker cup (securefit) "crossire" offset liner and cochr 28-mm/+12 femoral head.No information is available about primary arthroplasty or interval performance of the hip until a hip dislocation occurred on (b)(6) 2014, requiring a closed reduction; although, no further details were provided regarding the conditions surrounding this event nor specific details of treatment thereof, although later information reported that no surgery was performed around this time.Because no surgery had been performed, the subsequent clinical, x-ray and explant information that became available for the problems in 2018, can also be used for evaluation of the problems occurring in 2014.Conclusions: the medical review concluded the following: 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 dislocation occurring and requiring a closed reduction without revision surgery required at this time.Does the review identify any procedural related factors that contributed to the event? cup malposition in low effective inclination and high anteversion plus severe medialization of the cup; 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; severe obesity (bmi=39) as minor secondary factor.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices as also supported by the mar findings of 2018.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for the reported dislocation of patient's left hip on (b)(6) 2014.In providing medical records for a revision of patient's left hip on (b)(6) 2018, rep provided office notes which indicate the patient had a left hip dislocation (b)(6) 2014.None of the records provided indicate if, or how, the dislocation was addressed.Rep has no access to any further records due to surgeon and hospital policy.Update: medical review confirms that no revision surgery took place for the 2014 event; it was treated by closed reduction.Review also confirmed shell and stem malposition and impingement between the liner and the stem.

• Brand Name: UNKNOWN SECURFIT SHELL
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8152440
• MDR Text Key: 129970588
• Report Number: 0002249697-2018-03978
• Device Sequence Number: 1
• Product Code: JDG
• 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: 12/11/2018

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 Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• 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): Other
• Patient Age: 65 YR