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

Catalog Number 625-0T-32F

Device Problem Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2007

Event Type  malfunction  

Event Description

It was reported that two years after implant, patient had a little squeaking.It went away and came back now.The squeaking is louder and more severe.Patient's wife stated that patient is currently following up with surgeon.

Manufacturer Narrative

The catalog number and lot code were not provided.The patient's wife described the device as unknown left stryker ceramic hip.Additional information has been requested and if received, will be provided in the supplemental report.Device remains implanted.

Manufacturer Narrative

Catalog, lot, expiration, pma, and manufacturing date were updated.An event regarding audible noise involving a trident liner was reported.The event was confirmed.Device evaluation not performed as no items were returned, they remain implanted.Medical records indicate that the acetabular component appears somewhat more anteverted than normal.There may be a relationship between the described impingement of the prosthetic neck on the posterior acetabulum and the intermittent squeaking, which has apparently resolved.Subluxation with external rotation may result in metal transfer to the alumina head, which has been associated with squeaking phenomena.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.The exact cause of the event could not be determined however malpositioning of the acetabular shell may have lead to subluxation which has been associated with squeaking phenomena.No further investigation for this event is possible at this time.

Event Description

It was reported that two years after implant, patient had a little squeaking.It went away and came back now.The squeaking is louder and more severe.Patient's wife stated that patient is currently following up with surgeon.

• 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: 3604088
• MDR Text Key: 4067610
• Report Number: 0002249697-2014-00270
• Device Sequence Number: 1
• Product Code: MEH
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 24401202
• Other Device ID Number: 0710BCA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2007
• 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): Other
• Patient Age: 67 YR
• Patient Weight: 90