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

Catalog Number 625-0T-32E

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Ambulation Difficulties (2544)

Event Date 05/07/2007

Event Type  Injury  

Event Description

It was reported that the patients hip squeaks and there is shortness in the leg length.Yesterday, patient was walking and his hip gave out, he can¿t describe what happened, now hip is swollen.

Event Description

It was reported that the patients hip squeaks and there is shortness in the leg length.Yesterday, patient was walking and his hip gave out, he can¿t describe what happened, now hip is swollen.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.(b)(4).

Manufacturer Narrative

An event regarding squeaking was reported.The event was not confirmed.Device history review indicates the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicates there has been one other event for the reported lot.A trend request has been made.A review of the provided medical records and x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no patient demographics other than ¿well developed and well-nourished male¿, and no documentation of the event description are available.There has been a reported increase in squeaking phenomena of ceramic-ceramic hips associated with an acetabular component that is vertically positioned.This may be relevant in this case.More documentation is required to evaluate the event description.¿ based on the provided information, the event is not device related.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3619832
• MDR Text Key: 4160885
• Report Number: 0002249697-2014-00354
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2013

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: 08/31/2011
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 19985003
• Other Device ID Number: STERILE LOT# 0608RIRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2006
• 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): Other
• Patient Age: 51 YR