MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-10-36G

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported that there was suspected osteolysis due to wear.Intraoperatively corrosion under the femoral head, liner, and cup was found.(accolade stem stayed implanted.).

Manufacturer Narrative

The catalog number and lot code have not been provided.The device was reported as an unknown liner.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

(b)(6).An event regarding wear involving a trident liner was reported.The event was confirmed.Method & results: -device evaluation and results: evaluation of the insert indicated - burnishing,scratching and delamination were observed on areas of the acetabular insert.These are commonly identified damage modes in uhmwpe inserts.-medical records received and evaluation: insufficient records were provided for review.-device history review: the reported device was manufactured and accepted into final stock with no discrepancies.-complaint history review: there have been no other events for the reported lot id.Conclusions: a material analysis indicated the burnishing, scratching and delamination are commonly identified damage modes in uhmwpe inserts.The exact root cause of the wear cannot be determined as medical records, clinical history and operative reports are needed for further evaluation.

Event Description

It was reported that there was suspected osteolysis due to wear.Intraoperatively corrosion under the femoral head, liner, and cup was found.(accolade stem stayed implanted.).

• Brand Name: TRIDENT 10° X3 INSERT 36MM ID
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3761794
• MDR Text Key: 4415844
• Report Number: 0002249697-2014-01309
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 4D8MNA
• Other Device ID Number: STERILE LOT: MG0609I053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2006
• 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: 41 YR
• Patient Weight: 88