MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; IMPLANT

Catalog Number 542-11-50E

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 12/02/2014

Event Type  Injury  

Event Description

It was reported that patient was revised on a left hip due to a loose cup.

Manufacturer Narrative

Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: -a visual, functional and dimensional inspection was not performed as the device was not returned.-medical records received and evaluation: insufficient information was received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: TRIDENT PSL HA CLUSTER 50MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4354282
• MDR Text Key: 19086032
• Report Number: 0002249697-2014-04893
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 542-11-50E
• Device Lot Number: MLNK87
• Other Device ID Number: STERILE LOT MSHLP11A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• 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: 74 YR