MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 NON COL HO SIZE 14; HIP FEMORAL STEM

Model Number	L20314
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of loose stem.
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.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.A review of the photographic evidence cannot confirm the reported allegation.A radiolucent area was found between the superior area of the implant and the bone.However, the reported loosening could not be confirmed without a series of x-rays to review.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: CORAIL2 NON COL HO SIZE 14
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16087505
• Report Number: 1818910-2023-00138
• Device Sequence Number: 6686307
• Product Code: LZO
• UDI-Device Identifier: 10603295258056
• UDI-Public: 10603295258056
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2023

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: L20314
• Device Catalogue Number: L20314
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 02/18/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/13/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown