MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SYSTEM ONE BIPOLAR; HIP IMPLANT

Catalog Number 6074-4622

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988)

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

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient had procedure for revision on (b)(6) 2016.The physician thought the bipolar was worn out and removed it from the patient.

Manufacturer Narrative

An event regarding alleged "wear" involving a system one bipolar was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition.On the outer metallic side there are scratches in various areas.Examination of the returned device with material analysis engineer indicated there is damage consistent with impingement on the outer distal poly and explantation damage.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed based on examination of the returned device with material analysis engineer indicating there is damage consistent with impingement on the outer distal poly and explantation damage.However, the root cause could not be determined as insufficient medical information was provided.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Patient had procedure for revision on (b)(6) 2016.The physician thought the bipolar was worn out and removed it from the patient.

• Brand Name: SYSTEM ONE BIPOLAR
• Type of Device: HIP 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6391405
• MDR Text Key: 69484586
• Report Number: 0002249697-2017-00851
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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: 08/31/2015
• Device Catalogue Number: 6074-4622
• Device Lot Number: MJLHWK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2010
• 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