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

Catalog Number UNK_SHC

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

The catalog number and lot code were not identified in the article.The device was reported as an unknown accolade 1 stem.Should additional information become available, it will be provided in a follow up report upon completion of the investigation.Not available.

Event Description

A review of a us journal article, "catastrophic femoral neck failure after tha with the accolade i stem in three patients" by stryker ra in belgium, indicated the following: a (b)(6)-year-old male presented 7 years (80 months) after tha with left hip pain and no antecedent trauma.He was at home ambulating when his hip suddenly gave way.On presentation, the patient required a walker to ambulate.He presented with normal neurologic and vascular status to the affected left extremity.Radiographs showed a fracture of the left femoral stem at the head-neck junction of the trunnion.He underwent revision hip arthroplasty without complication, and removal of the implant showed a fracture of the femoral neck.There was no evidence of loosening of the femoral stem or acetabular component.Deep cultures were negative for infection.

Manufacturer Narrative

An event regarding a fracture involving an unknown accolade 1 stem was reported.The event was confirmed.Stem malposition was also confirmed from medical review.Method & results: -device evaluation and results: visual inspection: the device was not returned however an image of the device was provided.The image showed a fracture of the accolade stem trunnion.Bony ongrowth was also noted.Medical records received and evaluation: a review of the provided information by a clinical consultant concluded that : multiple procedure-related factors (stem position and use of skirted femoral head) as well as patient-related factors (mild overweight) might in concert have contributed to overload ending in a fatigue fracture of the accolade tmzf stem neck.There is not enough clinical information to confirm this with certainty and exclude additional risk factors of other origins.Conclusions: a review of the provided information by a clinical consultant concluded that : multiple procedure-related factors (stem position and use of skirted femoral head) as well as patient-related factors (mild overweight) might in concert have contributed to overload ending in a fatigue fracture of the accolade tmzf stem neck.Further information such as return of device, operative reports, additional xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

A review of a us journal article, "catastrophic femoral neck failure after tha with the accolade i stem in three patients" by stryker ra in (b)(4), indicated the following: a (b)(6)-year-old male presented 7 years (80 months) after tha with left hip pain and no antecedent trauma.He was at home ambulating when his hip suddenly gave way.On presentation, the patient required a walker to ambulate.He presented with normal neurologic and vascular status to the affected left extremity.Radiographs showed a fracture of the left femoral stem at the head-neck junction of the trunnion.He underwent revision hip arthroplasty without complication, and removal of the implant showed a fracture of the femoral neck.There was no evidence of loosening of the femoral stem or acetabular component.Deep cultures were negative for infection.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: HIP IMPLANT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5163123
• MDR Text Key: 28796558
• Report Number: 0002249697-2015-03416
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• 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; Other; Required Intervention
• Patient Age: 55 YR