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	Pain (1994); Ambulation or Postural Difficulties (2544); Thrombosis/Thrombus (4440)
Date of Event	05/05/2021
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
On (b)(6) 2021, patient received a right anterior approach total hip arthroplasty to address end-stage arthritis, utilizing ingrowth corail stem and pinnacle cup, with altrx polyethylene liner and ceramic femoral head.There were no complications.On (b)(6) 2021, patient presented in the office with sudden acute onset of calf pain, with difficulty walking.This was suspicious for possible deep vein thrombosis.Following a venous doppler examination on (b)(6) 2021, it was determined that the patient did have a confirmed non-occlusive deep vein thrombosis of the posterior tibial vein, extending from the calf to the ankle.Attending surgeon prescribed eliquis 10 mg bid for 7 days, then 5 mg bid after that, with reduction in all activities until seen by family physician to resume care.Date of implantation: (b)(6) 2021.Date of event (onset): (b)(6) 2021.(right hip).Treatment: injected medication - lovonox.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.Nothing is noted to suggest the products contributed to the reported problems.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 product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records reviewed: on (b)(6) 2021, patient received a right anterior approach total hip arthroplasty to address end-stage arthritis, utilizing ingrowth corail stem and pinnacle cup, with altrx polyethylene liner and ceramic femoral head.There were no complications.On (b)(6) 2021, patient presented in the office with sudden acute onset of calf pain, with difficulty walking.This was suspicious for possible deep vein thrombosis following a venous doppler examination on (b)(6) 2021, it was determined that the patient did have a confirmed non-occlusive deep vein thrombosis of the posterior tibial vein, extending from the calf to the ankle.Attending surgeon prescribed eliquis 10 mg bid for 7 days, then 5 mg bid after that, with reduction in all activities until seen by family physician to resume care.

• 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 IN 69801 ; FR 69801
• MDR Report Key: 11888542
• Report Number: 1818910-2021-11275
• Device Sequence Number: 17043220
• Product Code: LPH
• UDI-Device Identifier: 10603295258070
• UDI-Public: 10603295258070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: L20316
• Device Catalogue Number: L20316
• Device Lot Number: 5297109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 06/10/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/08/2021; 06/11/2021
• 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 NEUT 36IDX58OD; CORAIL2 NON COL HO SIZE 16; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE SECTOR II CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 111