MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92512
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907)
Date of Event	02/28/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, ¿metallosis and pseuodotumor.Replacement needed¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that corail2 std size 12 present signs of what appears to be bone ingrowth at the distal portion of the fixation surface.Additionally, wear was observed all over the surface of the taper, which could indicate micromotion between the interfaces of the stem and the femoral head.The observed condition of the device might contribute the reported metallosis event.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection and functional testing were not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the corail2 std size 12 would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : there is no evidence suggesting manufacturing or material error as a potential cause for the incident involving the asr platform.Where the product and lot code were provided, a manufacturing records evaluation (mre) was not performed.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that patient underwent revision due to metallosis and pseuodotumor.

• Brand Name: CORAIL2 STD SIZE 12
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19392309
• Report Number: 1818910-2024-11535
• Device Sequence Number: 7744038
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: 10603295168782
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• 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
• Report Date (Section B): 05/24/2024

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 Expiration Date: 03/28/2011
• Device Catalogue Number: 3L92512
• Device Lot Number: 2125246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2006
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASR ACETABULAR IMPLANT 62; DEPUY ASR XL FEM IMP SIZE 55; UNK HIP FEMORAL HEAD METAL ASR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown