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

Catalog Number UNK_REC

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/04/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding pain and injury involving an accolade stem and an unknown head was reported.Disassociation was confirmed following visual inspection of the provided x-rays and explanted devices.Device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Damage was observed on the taper of the head, likely from interacting with the trunnion of the accolade stem.Debris was also observed taper." medical records received and evaluation: a review of the provided medical records and x-rays concluded: procedure-related factors: heterotopic ossifications are a procedure-related complication of any hip arthroplasty with patient-related sensitivity factors as well present.Patient-related factors sensitivity for development of heterotopic ossifications has genetic predisposition.Device-related factors: none as also supported by mar findings.Diagnosis: heterotopic ossifications in the superior hip joint space have contributed to bony impingement in external rotation with a resultant overload condition.Progressive corrosion due to excessive micromotion has caused catastrophic trunnion failure with femoral head disassociation requiring revision." a review of the provided medical records and x-rays concluded "heterotopic ossifications in the superior hip joint space have contributed to bony impingement in external rotation with a resultant overload condition.Progressive corrosion due to excessive micromotion has caused catastrophic trunnion failure with femoral head disassociation requiring revision." no further investigation for this event is possible at this time.If additional information such as patient details, histopathology reports, additional x-rays and sticker sheets become available, this investigation will be reopened.

Event Description

Patient rh went to emergency room on saturday (b)(6) 2016 regarding pain in the hip area.Doctor contacted rep regarding revision of hip and surgery on (b)(6) 2016 and found the device came apart.

• Brand Name: UNKNOWN HEAD
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6139067
• MDR Text Key: 61246301
• Report Number: 0002249697-2016-03807
• Device Sequence Number: 1
• Product Code: OOG
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention
• Patient Age: 85 YR