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

Catalog Number 625-0T-32E

Device Problems Defective Component (2292); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 11/01/2014

Event Type  Injury  

Event Description

The surgeon reported that, following successful primary implantation with a trident cup and head, the patient allegedly presented with a squeaking hip and that allegedly because of the squeaking the surgeon took a decision to undertake revision surgery to replace the liner and head.Details of product codes and lot numbers for the liner and the head will follow.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown squeaking hip.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 audible noise involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar)."the insert and sleeve assembly is shown in figures 8 and 9.Neck impingement damage was observed on the distal rim (figure 9), an indication of likely contact with the stem.Explantation damage was observed on the proximal side of the sleeve.A wear scar was present on the articulating surface of the insert (figure 10).White-colored debris was present on the distal rim where the insert meets the sleeve" the mar concluded "no material or manufacturing defects were observed on the device features examined." -medical records received and evaluation: a medical review was not performed because insufficient information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: a material analysis was performed and concluded that "no material or manufacturing defects were observed on the device features examined." the exact cause of the event however could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.

Event Description

The operative report indicated that this was a routine primary through a lateral approach.At revision implants solidly fixed.Noted no fluid in hip at arthrotomy.

• 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: 4415986
• MDR Text Key: 5372715
• Report Number: 0002249697-2015-00034
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/15/2014

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: 02/29/2016
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 36159405
• Other Device ID Number: STERILE LOT: 1102LC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2011
• 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: 57 YR
• Patient Weight: 85