MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Model Number	L20310
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
After review of medical records the patient was revised for mechanical loosening of left total hip arthroplasty.It was indicated that the patient presented with increasing hip pain and inability to ambulate well and getting difficult to walk even with maximum assistance.Operative notes reported that there appears to be a subacute hematoma which was irrigated.The entire ste and head was removed as a single piece by hand as it was grossly loose.Doi: (b)(6) 2006; dor: (b)(6) 2019; 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 10
• 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: 10209217
• Report Number: 1818910-2020-14632
• Device Sequence Number: 3271111
• Product Code: KWA
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2010
• Device Model Number: L20310
• Device Catalogue Number: L20310
• Device Lot Number: 1904444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: ARTICULEZE M HEAD 36 MM +5; CORAIL2 NON COL HO SIZE 10; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54 MM; ARTICULEZE M HEAD 36 MM +5; CORAIL2 NON COL HO SIZE 10; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR