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

Catalog Number UNK_SHC

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Hip revised due to head disassociation.After accessing the hip implant black particulate infiltration of tissue was noted as well as worn trunnion.

Manufacturer Narrative

An event regarding disassociation between an unknown accolade stem and an unknown head was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as the device was not returned however, photographs were provided for review.The first photograph shows the unknown accolade stem still implanted in the patient with evidence of blackening of the tissue in the image provided, the other pictures show the explanted accolade stem.The trunnion appears worn and blackening is observed on the body of the device.-medical records received and evaluation: not performed as no medical records were returned for review.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: an event regarding disassociation between an accolade stem and an unknown head was reported; this event was not confirmed.However photographs of the stem were provided for review.The first photograph shows the unknown accolade stem still implanted in the patient with evidence of blackening of the tissue in the image provided, the other pictures show the explanted accolade stem.The trunnion appears worn and blackening is observed on the body of the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Hip revised due to head disassociation.After accessing the hip implant black particulate infiltration of tissue was noted as well as worn trunnion.

Manufacturer Narrative

An event regarding disassociation between an unknown accolade stem and an unknown head was reported.Wear of the stem trunnion was confirmed; disassociation was not.Method & results: product evaluation and results: not performed as the device was not returned however, photographs were provided for review.The first photograph shows the unknown accolade stem still implanted in the patient with evidence of blackening of the tissue in the image provided, the other pictures show the explanted accolade stem.The trunnion appears worn and blackening is observed on the body of the device.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: an event regarding disassociation between an accolade stem and an unknown head was reported.No product was returned, however photographs of the stem were provided for review.The first photograph shows the unknown accolade stem still implanted in the patient with evidence of blackening of the tissue in the image provided, the other pictures show the explanted accolade stem.The trunnion appears worn and blackening is observed on the body of the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Hip revised due to head disassociation.After accessing the hip implant black particulate infiltration of tissue was noted as well as worn trunnion.

• Brand Name: UNKNOWN ACCOLADE TMZF
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8245504
• MDR Text Key: 132982998
• Report Number: 0002249697-2019-00175
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention