MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SELF CENT HIP 44X28 GRY; BIPOLAR HEAD

Catalog Number 103544000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/30/2014

Event Type  Injury  

Event Description

The patient was revised because of fractured poly of the bipolar head.

Manufacturer Narrative

The investigation is ongoing.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The patient was revised because of fractured poly of the bipolar head.Doi: (b)(6) 2005 - dor: (b)(6) 2014 (left hip).The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.A review of the device history records for the provided product and lot combination did not reveal any related manufacturing deviations or anomalies.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SELF CENT HIP 44X28 GRY
• Type of Device: BIPOLAR HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3830328
• MDR Text Key: 4450823
• Report Number: 1818910-2014-19429
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2014

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 Catalogue Number: 103544000
• Device Lot Number: Y5VDS1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2014
• Initial Date FDA Received: 05/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2004
• 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: 58 YR
• Patient Weight: 139