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

Catalog Number 623-00-36F

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been one more event for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: trident psl ha cluster 54mm; cat#542-11-54f; lot#8r50ay.Delta v-40 ceramic head 36/-2; cat#6570-0-436; lot#59460801.Size 7 accolade ii 132 deg; cat#6720-0737; lot#56926702.The 6.5 cancellous bone screw 25mm; cat#6720-0737; lot#643ek5.The 6.5 cancellous bone screw 25mm# cat#2030-6525-1; lot#rw45ja.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient underwent bilateral total hip replacement in (b)(6) 2017.The right hip (accompanying spreadsheet identifies left hip) started draining and patient reported increased pain.Patient was revised for infection.

• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7421219
• MDR Text Key: 105134897
• Report Number: 0002249697-2018-01081
• Device Sequence Number: 1
• Product Code: LHP
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 623-00-36F
• Device Lot Number: WM6N17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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: 69 YR
• Patient Weight: 64