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

Catalog Number	L20315
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Rash (2033); Discomfort (2330); Injury (2348); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	06/11/2012
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.
Event or Problem Description
New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.-litigation alleges severe pain, discomfort, inflammation, and elevated levels of cobalt chromium metal ions and particles in the blood and tissue surrounding the implant.Doi: (b)(6) 2008 - dor: none reported; (right hip).Patient is a resident of (b)(6).Update: 11/2/2012- pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update ad: 13 apr 2018-pfs, ppf, medical record and sticker sheet received.Pinnacle plaintiff fact sheet and plaintiff profile form alleges pain, injury and difficulty walking.Updated complaint information.Doi: (b)(6) 2008; dor: not revised; right hip.
Event or Problem Description
Update ad 13 apr 2018: pfs, ppf, medical record and sticker sheet received.Pinnacle plaintiff fact sheet and plaintiff profile form alleges pain, injury, difficulty walking and rashes in the surgical area.Updated complaint information.After the review of medical records, there is no revision and no new information added that will change the mdr reportability.Doi: (b)(6) 2008; dor: not revised; right hip.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > the dhr analysis of batch 2471178/ l20315 shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.This batch was manufactured in november 2007.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
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7501991
• Report Number: 1818910-2018-59249
• Device Sequence Number: 1550923
• Product Code: KWA
• UDI-Device Identifier: 10603295258063
• UDI-Public: 10603295258063
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K04292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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 Catalogue Number: L20315
• Device Lot Number: 2471178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 09/09/2019
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/10/2018; 09/10/2019
• 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