MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL HEAD; UNKNOWN HIP IMPLANT

Catalog Number UNK_JR

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 07/08/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding crack/fracture involving an accolade stem and unknown femoral head was reported.Crack/fracture was not confirmed however disassociation was confirmed on review of the provided medical records by a clinical physician.Method & results: device evaluation and results: the device was not returned however a photo of the explanted stem was provided, this showed damage on the trunnion of the stem consistent with loss of taper lock with the metal head.Medical records received and evaluation: a review of the provided medical records by a clinical consultant noted; conclusion of assessment.Review of these records confirms dissociation of a femoral head and trunnion with significant damage and loss of material on the superior aspect of the trunnion along with notching and loss of material from the inferior aspect of the neck occurred, however, the root cause cannot be determined as insufficient information was available conclusion: a medical review confirmed disassociation however the root cause could not be determined.Further information such as operative reports, surgical implant records from the surgeries, dated pre and post op x-rays/ imaging from the index and revision surgeries, outpatient office/clinic notes & implant retrieval with material analysis are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Fractured neck of prosthesis.Update per med review: stem and head disassociation were confirmed per provided images.

• Brand Name: UNKNOWN FEMORAL HEAD
• Type of Device: UNKNOWN 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8091248
• MDR Text Key: 127948590
• Report Number: 0002249697-2018-03785
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• 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: 10/24/2018
• 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: 89 YR
• Patient Weight: 70