MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM 1; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Metal Shedding Debris (1804); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

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.Device 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 with 8 months of increasing right hip and groin pain after a right tha 10 years (120 months) before.He had tried physical therapy, ordered by his primary care physician, for relief of his pain and had been using a cane for ambulatory assistance.At presentation, his physical examination was remarkable for tenderness over the greater trochanter, trendelenberg gait pattern, and limited rom of the right hip.Radiographs showed evidence of failure at the head-neck junction with extensive heterotopic ossification of the right hip, and an acetabular cup abduction angle of 59.At the time of revision, the components showed catastrophic failure of the trunnion with varus deformity of the metal head on the trunnion causing local metallosis in and around the hip.The acetabular and femoral components were revised without intraoperative complication, and postoperative radiographs showed revision of the femoral stem and substantial residual heterotopic bone.The acetabular component also was revised owing to the abduction position.

Manufacturer Narrative

An event regarding disassociation involving an unknown accolade 1 stem was reported.The event was confirmed.Stem malposition and an adverse local tissue reaction (altr) were also confirmed from medical review.Method & results: -device evaluation and results: visual inspection: the image showed severe damage to 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 : an adverse combination of multiple procedure-related factors (cup and stem malposition) plus patient-related factors (heterotopic ossifications) resulted in functional stiffness of the hip joint with consequent overload in the arthroplasty bearing ending in catastrophic trunnion damage with secondary metallosis requiring revision.Conclusions: a review of the provided information by a clinical consultant concluded that: an adverse combination of multiple procedure-related factors (cup malposition in high inclination, stem malposition in high position and use of an extra long 36-mm/+10-mm skirted head) plus patient-related factors (brooker grade-4 heterotopic ossifications) resulted in functional stiffness of the hip joint with consequent overload in the arthroplasty bearing ending in catastrophic trunnion damage with secondary metallosis requiring revision.Further information such as return of device, operative reports, additional x-rays, 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 with 8 months of increasing right hip and groin pain after a right tha 10 years (120 months) before.He had tried physical therapy, ordered by his primary care physician, for relief of his pain and had been using a cane for ambulatory assistance.At presentation, his physical examination was remarkable for tenderness over the greater trochanter, trendelenberg gait pattern, and limited rom of the right hip.Radiographs showed evidence of failure at the head-neck junction with extensive heterotopic ossification of the right hip, and an acetabular cup abduction angle of 59.At the time of revision, the components showed catastrophic failure of the trunnion with varus deformity of the metal head on the trunnion causing local metallosis in and around the hip.The acetabular and femoral components were revised without intraoperative complication, and postoperative radiographs showed revision of the femoral stem and substantial residual heterotopic bone.The acetabular component also was revised owing to the abduction position.

• Brand Name: UNKNOWN ACCOLADE STEM 1
• 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: 5163500
• MDR Text Key: 28816953
• Report Number: 0002249697-2015-03420
• 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: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• 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
• Date Manufacturer Received: 11/12/2015
• 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: 72 YR