MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; IMPLANT

Catalog Number 509-02-60F

Device Problems Mechanical Problem (1384); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/30/2015

Event Type  Injury  

Event Description

It was reported that the patient had a hip revision due to disassociation of mdm metal liner separating from shell.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported to be an unknown shell.It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Manufacturer Narrative

An event regarding disassociation involving a mdm liner and a tritanium shell was reported.The event was confirmed from the x-ray provided.Method & results: a visual, functional and dimensional inspection was not performed as the device was not returned for analysis.A review of the provided information by a clincal consultant could confirm the event from the x-ray provided.However operative reports and examination of explanted components are needed to evaluate the event further.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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, operative reports,patient history & follow-up notes are needed to investigate this event further.If additional information or device becomes available, this investigation will be reopened.

Event Description

It was reported that the patient had a hip revision due to disassociation of mdm metal liner separating from shell.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4863509
• MDR Text Key: 5862525
• Report Number: 0002249697-2015-02047
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2015

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: 09/30/2018
• Device Catalogue Number: 509-02-60F
• Device Lot Number: MMLYR0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2013
• 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