MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number 6020-0537

Device Problems Detachment Of Device Component (1104); Disassembly (1168); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Injury (2348); No Information (3190)

Event Date 04/02/2014

Event Type  Injury  

Event Description

The femoral head disassociated off an accolade stem.The surgeon commented on trunnion wear and proceeded to a fully coated ha stem.

Manufacturer Narrative

An event regarding trunnion wear involving an accolade tmzf hip stem #5 was reported.The event was not confirmed.Device evaluation not performed as no items were returned.Medical records evaluation not performed as no items were returned.A device history review indicated all devices accepted into final stock met specifications.There have been no other events for the lot referenced.The exact cause of the event could not be determined because further information is needed.No further investigation for this event is possible at this time.

Event Description

The femoral head disassociated off an accolade stem.The surgeon commented on trunnion wear and proceeded to a fully coated ha stem.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

An event regarding trunnion wear involving an accolade tmzf hip stem #5 was reported.The event was confirmed.Method & results: device evaluation and results: not performed as no items were returned, photographs of the explanted devices were provided.The photo that shows a metal head with lot id 21297003 shows a explanted stem some debris and damage almost oval trunnion.There is a stem that shows damage on the trunnion area with some explantation marks and cover in body fluids.Conclusions: the event was confirmed from the photographs provided of the disassociation of the head from the stem, unfortunately the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The femoral head disassociated off an accolade stem.The surgeon commented on trunnion wear and proceeded to a fully coated ha stem.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• Type of Device: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• 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: 3764475
• MDR Text Key: 15329310
• Report Number: 0002249697-2014-01478
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 6020-0537
• Device Lot Number: 22442903
• Other Device ID Number: STER LOT: 0705KIRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2007
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 132