MAUDE Adverse Event Report: DEPUY FRANCE SAS ¿ 3003895575 CORAIL2 NON COL HO SIZE 15; HIP FEMORAL STEM/SLEEVE

Catalog Number	L20315
Medical Device Problem Codes	Corroded (1131); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/07/2014
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - litigation papers allege the patient suffers from pain, metallosis, the inability to walk and elevated metal ion levels.Doi: (b)(6) 2009 (left hip).Dor: no date set as of yet.Resident of (b)(6).Update 9/19/12 - plaintiff's preliminary disclosure form was received, which identified part/lot information and correct date of implant.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Doi: (b)(6) 2009.Update 07 april 2014 der received hospital (b)(4).Dor (b)(6) 2014.Additional product added - taper sleeve.Update aug 4, 2017: medical records received.After review of the medical records for the mdr reportability, patient was revised to address painful prosthesis and rising elevated metal levels.Revision notes reported grayish brownish type fluid shooting out under pressure (water-fountain effect) associated with metal on metal reaction, and tremendous amount of burnishing around the trunnion.Added stem to the complaint due to elevated metal ions.There were no laboratory results provided for the elevated metal ions.This complaint was updated on aug 17, 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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.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 15
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS ¿ 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone alpes 69801 ; FR 69801
• MDR Report Key: 6837844
• Report Number: 1818910-2017-23976
• Device Sequence Number: 800867
• Product Code: KWA
• UDI-Device Identifier: 10603295258063
• UDI-Public: 10603295258063
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2012
• Device Catalogue Number: L20315
• Device Lot Number: 2351858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 111