MAUDE Adverse Event Report: DEPUY FRANCE SAS CORAIL2 NON COL HO SIZE 11; HIP FEM STEM

Catalog Number L20311

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/07/2014

Event Type  Injury  

Manufacturer Narrative

Patient was revised to address periprosthetic fracture and subsidence.The stem subsided and became loose due a trauma from a fall.Doi: (b)(6) 2013 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.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.

Event Description

Patient was revised to address periprosthetic fracture and subsidence.The stem subsided and became loose due a trauma from a fall.

Manufacturer Narrative

Additional narrative:the device associated with this report was not returned.A search of the complaint database and/or dhr review was not possible as the product and lot code required was not provided.The investigation could not draw any conclusions regarding the reported event with the information available.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL2 NON COL HO SIZE 11
• Type of Device: HIP FEM STEM
• Manufacturer (Section D): DEPUY FRANCE SAS; 7 allée irène joliot curie; bp 256; saint priest cedex 6980 1; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS; 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: 3637716
• MDR Text Key: 11805026
• Report Number: 1818910-2014-13044
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

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: L20311
• Device Lot Number: 5214848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 02/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• 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): Required Intervention