MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; IMPLANT

Catalog Number 6020-3535

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414); Test Result (2695)

Event Date 11/27/2014

Event Type  Injury  

Event Description

Surgeon informed sales rep.That revision surgery was made as 63 year old female patient had a severe thigh pain.Outcome metallosis and fluids in joint.Basic alval symptoms.The head and poly (x3) liner was revised.Stem (item# 6020-3535, lot 39172402) was left to place although trunion was damaged.Revised liner was damaged during the procedure so it is not available for investigation.36 mm ceramic head with metal sleeve was used in replacement device.Also new 36mm x3 liner (item# 623-00-36d, lot mlnjv3) was used.

Manufacturer Narrative

It was noted that the device is not available for evaluation because it remains implanted in the patient.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot referenced.The event concerning the corrosion of the stem could not be confirmed nor the root cause determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Surgeon informed sales rep.That revision surgery was made as (b)(6) year old female patient had a severe thigh pain.Outcome metallosis and fluids in joint.Basic alval symptoms.The head and poly (x3) liner was revised.Stem (item# 6020-3535 lot 39172402) was left to place although trunion was damaged.Revised liner was damaged during the procedure so it is not available for investigation.36 mm ceramic head with metal sleeve was used in replacement device.Also new 36mm x3 liner (item# 623-00-36d lot mlnjv3) was used.

• Brand Name: ACCOLADE 132 SIZE 3.5
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill 00000 ; EI 00000
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4354060
• MDR Text Key: 17572960
• Report Number: 0002249697-2014-04852
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 6020-3535
• Device Lot Number: 39172402
• Other Device ID Number: STERILE LOT 12020CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2012
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 75