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

Catalog Number 625-0T-32F

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Additional devices listed in this report: cat # 6051-0935s, lot # mjn3jh, description: secur-fit max 132 hip stem #9.Cat # 542-11-50e, lot # 6l16yp, description: trident psl ha cluster 50mm.Cat # 17-3200e, lot # 3 36808301, description: alumina c-taper head 32mm/0.Cat # 2030-6520-1, lot # mkerj6 and mkj8ym, description: 6.5 cancellous bone screw.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Event Description

It was reported that the patient had a primary hip operation (b)(6) 2011 and now feels pain.

Manufacturer Narrative

A patient reported an event regarding pain.The event was not confirmed and the root cause of the reported pain could not be determined due to the minimal information received.Device history review for all of the reported devices in each lot provided indicated that all devices accepted into final stock conformed to specification.A complaint history review could not be performed for the reported lot codes since no product specific failure mode was identified.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.

Event Description

It was reported that the patient had a primary hip operation (b)(6) 2011 and now feels pain.

• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5007733
• MDR Text Key: 23149746
• Report Number: 0002249697-2015-02685
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 33866802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2010
• 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