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

Catalog Number 540-11-50E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported patient was complaining of discomfort and pain in her right hip.The cup, liner and ball are removed.Implants are retained by the hospital.

Manufacturer Narrative

Additional devices listed in this report: cat 6021-0130, accolade plus tmzf hip stem #1, lot code 26465903.Cat 6565-0-032, alumina v40-femoral head 32mm, -4mm nk lot code 26002401.Cat 625-0t-32e, trident alumina insert, lot code 26919801.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 devices are not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

The patient is (b)(6).An event regarding malposition involving a trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.-medical records received and evaluation: a review of the provided information by a clinical consultant could not determine a root cause nor confirm the event.-device history review: a device history review confirmed all devices were manufactured and accepted into finished goods with no reported discrepancies.-complaint history review: a complaint history review confirmed no similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was received.Further information such as return of device, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported patient was complaining of discomfort and pain in her right hip.The cup, liner and ball are removed.Implants are retained by the hospital.

• Brand Name: TRIDENT PSL HA SOLID BACK 50MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4334242
• MDR Text Key: 5140854
• Report Number: 0002249697-2014-04742
• 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,Followup
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 540-11-50E
• Device Lot Number: L3VMJE
• Other Device ID Number: STERILE LOT MSHEK10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2008
• 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: 63 YR
• Patient Weight: 62