MAUDE Adverse Event Report: DEPUY FRANCE SAS ¿ REG. # 3003895575 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM/SLEEVE

Catalog Number L20312

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 04/10/2014

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2014 by the same surgeon due to dislocation.The stem had appeared to have subsided.

Manufacturer Narrative

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

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.No further event information or investigational inputs were provided to customer quality.The investigation can draw no conclusions with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been identified.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

• Brand Name: CORAIL2 NON COL HO SIZE 12
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS ¿ REG. # 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 6980 1; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS ¿ REG. # 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 6980 1; FR 69801
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3751911
• MDR Text Key: 4555011
• Report Number: 1818910-2014-16892
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2014

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: Physician
• Device Catalogue Number: L20312
• Device Lot Number: 5219020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 04/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/23/2014; 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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): Required Intervention