MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 18; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92508
Medical Device Problem Codes	Metal Shedding Debris (1804); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Pinnacle litigation received.Litigation alleges that plaintiff has suffered and continues to suffer both injuries and damages, including but not limited to: past, present and future physical and mental pain.Doi: (b)(6) 2010 - dor: (b)(6) 2017 (unknown hip).
Event or Problem Description
Ppf and sticker sheets received.Ppf alleges metal wear/metallosis confirmed in medical records and elevated metal ions confirmed in medical records.Cup was added since ppf record indicated that it was removed.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL AMT COLLAR SIZE 18
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : 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: 7299009
• Report Number: 1818910-2018-54172
• Device Sequence Number: 16623787
• Product Code: KWA
• UDI-Device Identifier: 10603295168744
• UDI-Public: 10603295168744
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2018

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 Expiration Date: 06/13/2012
• Device Catalogue Number: 3L92508
• Device Lot Number: 2382526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 10/26/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 06/08/2018; 10/29/2018
• 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: 55 YR
• Patient Weight: 134