MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CORAIL2 NON COL HO SIZE 13; HIP FEMORAL STEM

Model Number	L20313
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Osteolysis (2377); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	07/03/2019
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
Facts alleged and reported by the applicant.The patient has bilateral hip osteoarthritis.The patient underwent surgery for the placement of a hip replacement.The intervention consisted of a bilateral hip replacement.The surgical intervention was performed and the prosthesis placed was made by j&j.In 2019, the patient began to experience hip pain and an mri was performed.The result of the mri was a synovitis supposedly caused by a loosening of the prosthesis in place.The diagnosis would have been qualified as metallosis.The patient underwent surgery to replace the prosthesis.This new intervention was also performed in the same previous hospital and a new prosthesis also from j&j would have been placed.The intervening physician in both surgeries was the same.Economic request: the patient's claim is compensation for damages caused by the replacement of prostheses and is (b)(6) plus costs.The patient explained that his claim is made up of the items: medical and pharmacy expenses (prosthetics); psychophysical disability; loss of profit; emergent damage (psychological treatment); and moral damage.Mediation procedure: a new hearing date was set.The patient's attorney agreed to send us the medical history.As soon as we receive it, we will send it to you.Doi: (b)(6) 2009.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.Device history lot : a device history record (dhr) review was conducted previously on (b)(4).The dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.

• Brand Name: CORAIL2 NON COL HO SIZE 13
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12672192
• Report Number: 1818910-2021-23115
• Device Sequence Number: 4714093
• Product Code: LZO
• UDI-Device Identifier: 10603295258049
• UDI-Public: 10603295258049
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 2746392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM; CORAIL2 NON COL HO SIZE 13; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male