MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 52MM; IMPLANT

Catalog Number 542-11-52E

Device Problem Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 02/06/2014

Event Type  Injury  

Event Description

Revised ceramic insert, psl cup, 3 screws and alumina head.Patient complained of noise coming from hip.Psl cup, 2 screws, and mdm insert were used as replacement device.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.(b)(4).

Manufacturer Narrative

Corrected data: explant date.An event regarding noise coming from a hip involving a trident shell was reported.Previous reported event indicate that noise from the hip is generated from the ceramic-on-ceramic bearing.The subject acetabular shell is not part of the ceramic bearing couple.There is no indication that the product reported in this investigation contributed to the event.No further investigation is required at this time.

Event Description

Revised ceramic insert, psl cup, 3 screws and alumina head.Patient complained of noise coming from hip.Psl cup, 2 screws, and mdm insert were used as replacement device.

• Brand Name: TRIDENT PSL HA CLUSTER 52MM
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3655774
• MDR Text Key: 4194963
• Report Number: 0002249697-2014-00604
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 542-11-52E
• Device Lot Number: 0HLMMD
• Other Device ID Number: STER. LOT MSH0708II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2007
• 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: 65 YR
• Patient Weight: 113