MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93711
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Initial report from study: clinical adverse event received for liner failure - wear and metallosis, alval, kippel trenaunay syndrome.Event is serious and is considered severe.Event is definitely related to device and not related to procedure.Date of implant: (b)(6) 2009, date of event: (b)(6) 2019, date of revision: (b)(6) 2020, (right hip).Revision of metal head and liner.Additional information received with following information: revision operative notes (b)(6) 2020 indicate the patient received a right total hip revision due to right hip pain, adverse local tissue reaction, poly liner wear and osteolysis of proximal femur and acetabulum.The surgery was completed without indication of complication by the surgeon.Upon entering the joint a massive pseudotumor was encountered along with osteolysis.Corrosion was noted on the femoral stem trunnion, polywear was noted on the liner.Blood loss of 1,000ml was noted, cell saver was utilized and returned 400ml of the patients own blood back to them.
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.Device history lot : as no other reports of any kind were identified over the previous five year period it is reasonable there was no error in the manufacturing or material of this product/lot combination that would be a contributing factor in the reported allegations.A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 11
• 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: 11278303
• Report Number: 1818910-2021-02394
• Device Sequence Number: 2590600
• Product Code: LZO
• UDI-Device Identifier: 10603295168881
• UDI-Public: 10603295168881
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2021

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 Model Number: 3L93711
• Device Catalogue Number: 3L93711
• Device Lot Number: 5003330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/22/2021; 03/05/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/04/2021; 03/07/2021
• 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: ALTRX +4 10D 36IDX54OD; CORAIL2 LAT COXA VARA SIZE 11; DLT TS CER HD 12/14 36MM +5.0; PINNACLE 100 ACET CUP 54MM; PINNACLE 100 ACET CUP 54MM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; ALTRX +4 10D 36IDX54OD; CORAIL2 LAT COXA VARA SIZE 11; DLT TS CER HD 12/14 36MM +5.0; PINNACLE 100 ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84