MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-36E

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Rep was notified that during a primary hip procedure, the x3 poly liner "didn't seem to be locking into cup properly".The rep was not present for the procedure and no additional information is available.The device is allegedly available for return.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9260153
• MDR Text Key: 186802134
• Report Number: 0002249697-2019-03651
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039542
• UDI-Public: 07613327039542
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 623-00-36E
• Device Lot Number: WX7PYH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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): Other