MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM ID; IMPLANT

Catalog Number 623-00-32C

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/29/2014

Event Type  Injury  

Event Description

We received a letter from the attorney of the patient with limited information.More information requested.

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs.The exact cause of the reported event cannot be determined.Additional device listed in this report is trident (tn) tc.Threaded cup, cat 7849-1-046c, lot code g29.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device implanted.

Manufacturer Narrative

An event regarding revision involving a trident insert was reported.The event was not confirmed.Method & results: device evaluation and results: the device was not available for evaluation.Medical records received and evaluation: records were not received for review.Device history review: the reported device was accepted into final stock with no reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: the exact cause of the event could not be determined based on the information provided.Further information such as post operative x-rays and the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.

Event Description

We received a letter from the attorney of the patient with limited information.More information requested.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM 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: 4282280
• MDR Text Key: 19304396
• Report Number: 0002249697-2014-04395
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

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: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 623-00-32C
• Device Lot Number: MJJ66X
• Other Device ID Number: STERILE LOT MSGJJ13E3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 68 YR