MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE 10 DEG INSERT; IMPLANT

Catalog Number 2041C-2846

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/13/2015

Event Type  malfunction  

Event Description

The surgeon noticed that the wire came off from the insert (inner diameter 28mm) during impacting the insert into the cup.Another insert (inner diameter 26mm) was used instead of it and the procedure was completed.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding seating/locking issues involving an omnifit liner was reported.The event was not confirmed.Method & results: device evaluation and results: the wire and insert were returned separately.The wire was bent and misshapen.There is a screw hole going all the way through the insert on the articulating surface.There is scratching and damage noted in the locking tab.All of these damage modes are consistent with attempted impaction and subsequent removal of the insert.A dimensional and functional inspection could not be performed due to the damaged described in the visual inspection medical records received and evaluation: insufficient information was received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: 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 operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.

Event Description

The surgeon noticed that the wire came off from the insert (inner diameter 28mm) during impacting the insert into the cup.Another insert (inner diameter 26mm) was used instead of it and the procedure was completed.

• Brand Name: CROSSFIRE 10 DEG 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: 4585189
• MDR Text Key: 5450469
• Report Number: 0002249697-2015-00665
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974685
• 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: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 2041C-2846
• Device Lot Number: 44874901
• Other Device ID Number: STERILE LOT 130XHP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• 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): Other