MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MD VIT SLV AND 2.0MM HOMOG CBL; BONE FIXATION CERCLAGE.

Catalog Number 6704-0-510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding revision involving a dall miles cable was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿there is no surgical pathology diagnostic of altr or metallosis, no examination of the explanted components, and no radiographic or clinical evidence of the primary stryker total hip arthroplasty components demonstrating loosening, wear or pathologic changes.After the (b)(6) 2017 revision in which the well-fixed stryker components were replaced with smith & nephew components, all subsequent complications related to the smith & nephew components.At the (b)(6) 2017 revision "no metallosis" was seen and a pre (b)(6) 2017 revision mri was not definitely diagnostic of trunnionosis or pseudotumor and was noted to have implant artifacts.A subsequent (b)(6) 2017 mars mri described a "suspected pseudotumor" at the iliopsoas tendon at a different site from the (b)(6) 2017 description, but also only "suspected".In summary, there is no evidence this clinical picture of complaints of hip pain of six months' duration occurring seven years post-implantation in a patient with chronic low back radicular pain and spine surgery, multiple hip injections and possible chronic hip infection is related to factors associated with the prosthetic hip components.¿ product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event for revision of the dall miles cable was confirmed.The revision surgery was noted as an unstable right hip for stem subsidence.The stem was a competitor stem which was removed and a larger competitor stem was implanted.The dall miles cables was removed based on the competitor stem¿s removal.

Event Description

It was reported by the patient that she underwent revision surgery of her right hip in (b)(6) 2017.Subsequently she dislocated three times and a spika cast was applied.Stem came out from brace and another revision had to be done.Updated per medical review: ¿on (b)(6) 2017 a revision right total hip arthroplasty (femur only) was performed for an "unstable right tha due to stem subsidence".The operative report notes general anesthesia and use of the previous incision, and during this surgery the s&n revision stem was changed to a larger stem, and uncomplicated surgery was described.¿ updated medical records noted devices were of competitor system, stem and head with 3 stryker cables for the event of subsidence.

• Brand Name: MD VIT SLV AND 2.0MM HOMOG CBL
• Type of Device: BONE FIXATION CERCLAGE.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7655382
• MDR Text Key: 112908006
• Report Number: 0002249697-2018-02011
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07613327036442
• UDI-Public: 07613327036442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

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 Expiration Date: 11/30/2021
• Device Catalogue Number: 6704-0-510
• Device Lot Number: 57682307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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; Other; Required Intervention