MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-10-36F

Device Problems Contamination (1120); Insufficient Information (3190)

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

Event Date 04/02/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: delta v-40 ceramic head 36/+5; cat# 6570-0-236; lot# 58066603 trident psl ha cluster 56mm; cat# 542-11-56f; lot# yk69t1 6.5 cancellous bone screw 40mm; cat# 2030-6540-1; lot# 4t3270 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Sales rep reported patient acquired an infection.Surgeon explanted acetabular cup, liner and femoral head.Replaced with cemented liner and new femoral head.

Manufacturer Narrative

An event regarding infection involving a trident insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: there have been no other events for the lot referenced and sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Sales rep reported patient acquired an infection.Surgeon explanted acetabular cup, liner and femoral head.Replaced with cemented liner and new femoral head.

• Brand Name: TRIDENT 10° 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6527284
• MDR Text Key: 73870290
• Report Number: 0002249697-2017-01394
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: (01)07613327039924(11)160826(17)210831(10)NE86PT
• 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,Followup
• Report Date: 07/28/2017

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: 08/31/2021
• Device Model Number: 623-10-36F
• Device Catalogue Number: 623-10-36F
• Device Lot Number: NE86PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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: 76 YR
• Patient Weight: 93