MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 13; HIP FEMORAL STEM

Model Number	L20313
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Limb Fracture (4518); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/14/2021
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
Surgeon was performing a hip revision to address a radiographically confirmed subtrochanteric hip fracture and associated presumptive hip dislocation.When the surgeon got into the hip capsule he found that the liner had dissociated and the metal femoral head was in direct contact with the acetabular shell and had evidently worn a hole through the acetabular shell.Surgeon also discovered a large quantity of black substance (presumed to be metal debris combined with tissue), both in the hip capsule and also down the femoral canal once the stem (which was loose), was removed.Surgeon went on to thoroughly wash out the hip capsule and femoral canal, before reaming the acetabulum and implanting a 60mm multihole gription pinnacle acetabular component and a 36/60mm neutral marathon liner, placing cables around the proximal femur to offer fracture fixation, and then preparing for and implanting a smith and nephew redapt revision hip stem and 36mm oxinium femoral head.Hip was then reduced, and proper wound closure took place.The surgery finished according to plan.Doi: 2014.Dor: (b)(6) 2021.Unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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
Additional information received indicated that there was a femur fracture, but not a dislocation.There was about 20 minutes surgical delay.

• Brand Name: CORAIL2 NON COL HO SIZE 13
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• MDR Report Key: 12413381
• Report Number: 1818910-2021-19170
• Device Sequence Number: 4698682
• Product Code: LZO
• UDI-Device Identifier: 10603295258049
• UDI-Public: 10603295258049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2021

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: L20313
• Device Catalogue Number: L20313
• Device Lot Number: 5218587
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 09/29/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/23/2021; 09/30/2021
• 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: ARTICUL/EZE BALL 32 +9 BL; CORAIL2 NON COL HO SIZE 13; PINN MAR NEUT 32IDX56OD; PINNACLE SECTOR II CUP 56MM; ARTICUL/EZE BALL 32 +9 BL; CORAIL2 NON COL HO SIZE 13; PINN MAR NEUT 32IDX56OD; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention