MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM

Model Number	L20312
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient underwent primary thr on (b)(6) 2014 where a corail pinnacle was utilized patient has presented with pain in the thigh.X rays indicate a possible loose femoral stem (windscreen wiper effect) a decision was made to revise the femoral stem.On opening the hip appeared that the stem was loose and had subsided.The stem was removed with minimal effort.The pinnacle poly liner was removed and replaced and the corail femoral stem was replaced with and s rom stem.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> yes, did the patient require revision surgery or hardware removal? -- yes, facility name of original implant -- cairns base hospital ?, was device explanted? -- true, hardware/explant removal due to: -- loose femoral stem , did patient require revision surgery? -- true, reason for revision surgery.--> pain, loose stem , patient status/ outcome / consequences -- , patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?-- pain due t0 loose femoral stem, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: -- unknown, is the patient part of a clinical study -- unknown, ip-01706794 device property of -- none, device in possession of -- none, ip-01706795 device property of -- none, device in possession of -- none, ip-01706796 device property of -- none, device in possession of -- none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst -- true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation, however x-ray was provided for review.The x-ray investigation revealed that there was no damaged or defect with the corail2 non col ho size 12.Asper visual inspection of the x-ray image a small gap between the device and the bone could be observed at the left femur.The reported condition of steam loosening could not be confirmed through 1 image.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.  device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received indicates that the prosthesis revised here is a corail as indicated in the cst.This is an all-uncemented prosthesis so no cement is used.
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.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL2 NON COL HO SIZE 12
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16822790
• Report Number: 1818910-2023-08816
• Device Sequence Number: 20579878
• Product Code: LZO
• UDI-Device Identifier: 10603295258032
• UDI-Public: 10603295258032
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

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: L20312
• Device Catalogue Number: L20312
• Device Lot Number: 5215963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 06/08/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: DELTA CER HEAD 12/14 32MM +9.; PINN MAR NEUT 32IDX58OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male