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

Catalog Number 625-0T-36G

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 06/26/2014

Event Type  Injury  

Event Description

Patient had his hip replaced in bloomington, il.The patient had fallen in 2012, since his fall he had felt unstable.His surgeon referred the patient to another surgeon for revision surgery at that time.It was noted in the case that patients' hip was unstable.The surgeon checked implants to see if they were stable.Both the femoral and acetabular components were well fixed.He then put a mdm liner in and was able to achieve stability.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding instability involving a trident alumina insert was reported.The event was not confirmed.Device evaluation not performed as the device was not returned for evaluation.Medical records was provided however were rejected for evaluation by a clinician due to insufficient information.Device history review.Indicated that the specified lot was accepted into final stock with no reported discrepancies.Complaint history review indicated that there have not been any other events for the specified lot.The reported event involves the patient sustaining a fall and a subsequent feeling of instability.The patient was revised to a mdm liner which provided stability.The femoral and acetabular components were well fixed.The exact cause of the event could not be determined because not enough information was provided.No further investigation for this event is possible at this time.

Event Description

Patient had his hip replaced in (b)(6).The patient had fallen in 2012, since his fall he had felt unstable.His surgeon referred the patient to another surgeon for revision surgery at that time.It was noted in the case that patients' hip was unstable.The surgeon checked implants to see if they were stable.Both the femoral and acetabular components were well fixed.He then put a mdm liner in and was able to achieve stability.

• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3940648
• MDR Text Key: 4530617
• Report Number: 0002249697-2014-02751
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 19563202
• Other Device ID Number: STER. LOT 0607KIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2006
• 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): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 112