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

Catalog Number UNK_SHC

Device Problems Corroded (1131); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/02/2018

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.Device not available.

Event Description

Doctor was performing a hip revision on a patient due to pain and instability.This patient had an accolade tmzf stem along with a metal v40 taper size 40 head.The doctor when removing the head noticed that there was metal shavings along with black tar looking metal pieces inside the v40 metal head and on the tmzf trunnion.The doctor cleaned off the neck and we put on a v40 to c-taper conversion sleeve.Then put on a c-taper ceramic 28 +5 head with the mdm poly liner and the mdm metal liner inside the shell.

Event Description

Doctor was performing a hip revision on a patient due to pain and instability.This patient had an accolade tmzf stem along with a metal v40 taper size 40 head.The doctor when removing the head noticed that there was metal shavings along with black tar looking metal pieces inside the v40 metal head and on the tmzf trunnion.The doctor cleaned off the neck and we put on a v40 to c-taper conversion sleeve.Then put on a c-taper ceramic 28 +5 head with the mdm poly liner and the mdm metal liner inside the shell.

Manufacturer Narrative

An event regarding corrosion involving an unknown stem was reported.Corrosion was confirmed to be present by the returned images of the explanted head.Method & results: -product evaluation and results:not performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: provided picture of the explanted head confirms corrosion.Need primary and revision operative notes, office/clinical notes, histopathology, serial x-rays and examination of the explanted devices.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: the pictures provided confirm corrosion.It was noted that the doctor cleaned off the neck which with the confirmed corrosion of the head would indicate that the corrosion extended to the stem.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative notes, office/clinical notes, histopathology, serial x-rays and examination of the explanted devices are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN ACCOLADE TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7476907
• MDR Text Key: 107020839
• Report Number: 0002249697-2018-01280
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention