MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36F

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Patient was revised on hip due to infected joint.Doctor removed head and insert.

Manufacturer Narrative

Catalog number and lot code of other device listed in this report: cat # 6260-9-136, lot # mmtmk0 description: v40 cocr lfit head 36mm/0.At this time, it cannot be determined if these devices may have caused or contributed to the patient¿s experience.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Not returned to manufacturer.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot.Patient details were reviewed and no indication was found that the event was related to device design, materials, or manufacturing.The event was confirmed but the root cause of the reported event could not be determined due to the minimal information received.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

Patient was revised on hip due to infected joint.Doctor removed head and insert.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4372378
• MDR Text Key: 5232645
• Report Number: 0002249697-2014-05042
• Device Sequence Number: 1
• Product Code: LPH
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

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: Other
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 623-00-36F
• Device Lot Number: MNKX5W
• Other Device ID Number: STERILE LOT# MSGNK26J7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 78