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

Catalog Number UNK_REC

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 metal head.Should additional information become available, it will be provided in a follow up report upon completion of the investigation.

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) 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 stem was reported.The medical review confirmed use of extra long+8-mm skirted head on the stem.Method & results: -device evaluation and results: visual inspection: the device was not returned however an image of the device was provided.The image of the metal head was incomplete but showed that it was attached to the trunnion of the accolade stem.-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 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5163473
• MDR Text Key: 28807452
• Report Number: 0002249697-2015-03417
• 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_REC
• 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