MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36E

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/29/2015

Event Type  Injury  

Event Description

Patient's left hip was revised due to recurrent dislocations - patient's primary surgery utilized biomet components done on an unknown date/location.The primary biomet hip components were revised on (b)(6) 2014 to include a trident shell and stryker liner, biomet stem and head remained.Surgeon replaced with a stryker constrained liner and the ball/head with a biomet part to match implanted biomet stem.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Manufacturer Narrative

Based on the provided information it has been determined that this event is associated with an off-label application.As per qin 4350, rev h, stryker product should not be used with competitors¿ devices because design, material, or tolerance differences may lead to premature device and/or function failure.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient's left hip was revised due to recurrent dislocations - patient's primary surgery utilized biomet components done on an unknown date/location.The primary biomet hip components were revised on (b)(6) 2014 to include a trident shell and stryker liner, biomet stem and head remained.Surgeon replaced with a stryker constrained liner and the ball/head with a biomet part to match implanted biomet stem.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4863507
• MDR Text Key: 21066771
• Report Number: 0002249697-2015-02045
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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
• Report Date: 05/29/2015

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 623-00-36E
• Device Lot Number: MNMKM4
• Other Device ID Number: STERILE LOT# MSGNM19E7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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: 50 YR
• Patient Weight: 61