MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 54MM; IMPLANT

Catalog Number 540-11-54F

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Test Result (2695)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported that revision ltha painful hip due to loose femoral component cobalt level 8.

Manufacturer Narrative

An event regarding a loose femora component involving a trident psl ha solid back 54mm was reported.The event was confirmed.Device evaluation and results: not performed as no device was returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated, ¿no evidence for device-related factors and as such this pi case is not device-related.¿ -device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the investigation concluded that shell malpositioning likely caused or contributed to the reported femoral loosening.The cup was implanted with absent anteversion and consequently impingement became an issue under daily activity conditions.Impingement causes an overload condition in the bearing section of the arthroplasty and this caused excessive rotational torque on the accolade stem resulting in stem loosening or lack of bone ingrowth in the first place.The same overload condition caused excessive micromotion in the femoral head taper connection contributing to an increase in cobalt release.No action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.

• Brand Name: TRIDENT PSL HA SOLID BACK 54MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4130388
• MDR Text Key: 4791333
• Report Number: 0002249697-2014-03688
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 540-11-54F
• Device Lot Number: E2NMDD
• Other Device ID Number: STERILE LOT MSH0702SS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2007
• 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: 73 YR
• Patient Weight: 120