MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 16; HIP FEMORAL STEM

Model Number	L20316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Pcf and medical records received.Pcf has no allegations reported.After review of medical records, patient was revised due to severe adverse local tissue reaction with metal debris and massive osteolysis.Operative notes indicated elevated metal level, a large amount of necrotic reactive debris and bone loss.There was a large amount of fluid in the joint and a large amount of abnormal reactive tissue and also represented some necrotic muscle.There was some scar tissue identified in the periformis.Doi: (b)(6) 2008, dor: (b)(6) 2020, (left hip).
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.

• Brand Name: CORAIL2 NON COL HO SIZE 16
• 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: 10234370
• Report Number: 1818910-2020-15015
• Device Sequence Number: 13596422
• Product Code: KWA
• UDI-Device Identifier: 10603295258070
• UDI-Public: 10603295258070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K04299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 11/30/2012
• Device Model Number: L20316
• Device Catalogue Number: L20316
• Device Lot Number: 2487980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36 MM +8.5; PINN CAN BONE SCREW 6.5 MMX25 MM; PINNACLE BONE SCREW 70 MM; PINNACLE MTL INS NEUT36IDX64OD; PINNACLE SECTOR II CUP 64 MM; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36 MM +8.5; PINN CAN BONE SCREW 6.5 MMX25 MM; PINNACLE BONE SCREW 70 MM; PINNACLE MTL INS NEUT36IDX64OD; PINNACLE SECTOR II CUP 64 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR