MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-28D

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Toxicity (2333)

Event Date 05/07/2014

Event Type  Injury  

Event Description

It was reported that as per the surgeon there was impingement at the 2 o'clock position with evidence of cocr metallosis.Previous dictation shows 1 dislocation immediately post op of original surgery with recurrent subluxation.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding dislocation involving a trident liner was reported.The event was confirmed.A material analysis indicated the damage on the returned liner may have generated metallic debris in vivo.This is as a result of impingement due to a malpositioned cup.Medical records indicate - patient-related factors of high activity level associated with young age plus early postoperative capsular laxity potentially might have acted as secondary factor although cup position remains the principal problem.As such root causer of failure is mainly procedure-related with possible a secondary contribution by patient-related factors without evidence for device-related factors as also supported by the mar findings.This pi case is not device-related.A device history review indicated that the device was manufactured and accepted into final stock.There have been no other events for the reported lot.The results of the investigation indicate the dislocation, impingement and metal debris were caused by malposition of the cup and a highly active patient.The reported event is not device related.

Event Description

It was reported that as per the surgeon there was impingement at the 2 o'clock position with evidence of cocr metallosis.Previous dictation shows 1 dislocation immediately post op of original surgery with recurrent subluxation.

• Brand Name: TRIDENT ALUMINA INSERT
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3897796
• MDR Text Key: 4654077
• Report Number: 0002249697-2014-02440
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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: 06/03/2014

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: 06/30/2012
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 23395501
• Other Device ID Number: STER. LOT 0706RIRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2007
• 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: 33 YR
• Patient Weight: 68