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

Catalog Number 623-00-36G

Device Problem Material Twisted/Bent (2981)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/13/2014

Event Type  Injury  

Event Description

The clinical study investigator reported via the clinical research associate that the patient was admitted to hospital and underwent a manipulation procedure of their hip replacement under anaesthetic on (b)(6) 2014.The clinical study investigator reported that the patient had twisted their hip whilst getting out of a chair at home.The patient is currently a participant in a stryker clinical study.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Manufacturer Narrative

Corrected age at time of event based on additional information.The patient is (b)(6) centimeters in height.An event regarding dislocation due to shell malposition involving a trident 0° x3 insert 36mm id was reported.The reported event is for dislocation.A review of the provided medical records by a clinical consultant indicated that the root cause of the dislocation was shell malposition.Based on the provided information, the product reported in this investigation did not contribute to the event.

Event Description

The (b)(4) study investigator reported via the (b)(4) associate that the patient was admitted to hospital and underwent a manipulation procedure of their hip replacement under anaesthetic on (b)(6) 2014.The (b)(4) study investigator reported that the patient had twisted their hip whilst getting out of a chair at home.The patient is currently a participant in a (b)(4) study.

• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3689943
• MDR Text Key: 4302883
• Report Number: 0002249697-2014-00804
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

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: 04/30/2017
• Device Catalogue Number: 623-00-36G
• Device Lot Number: 39945601
• Other Device ID Number: STER. LOT 1204D261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2011
• 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: 73 YR
• Patient Weight: 109