MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).H4: the information provided regarding the manufacturing date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.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
Update ad 14 jun 2024 medical records received : patient underwent revision due to extensive metallosis involving proximal femur, hip abductor musculature, trochanteric bursa and hip capsule with intact fixation of distal femoral stem and acetabular component.The surgery entailed removal of the stem through an extended trochanteric osteotomy; removal of the metal liner as well as removal of the acetabular cup.Extensive brown colored fluid was found in the hip capsule and metal debris was debrided throughout the hip.A constrained liner was used to mitigate the potential for postoperative instability as the surgeon did not feel a dual mobility articulation would provide adequate stability in the absence of a fully intact abductor mechanism.Extensive abductor damage was found.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Affected hip : right.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#3l92513 / lot#2399329 combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#3l92513 / lot#2399329 combination.

• Brand Name: CORAIL2 STD SIZE 13
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19610482
• Report Number: 1818910-2024-13896
• Device Sequence Number: 17725981
• Product Code: LZO
• UDI-Device Identifier: 10603295168799
• UDI-Public: (01)10603295168799(10)2399329(17)120708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2012
• Device Catalogue Number: 3L92513
• Device Lot Number: 2399329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2020
• 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: 12/14 ARTICUL 40MM M SPEC+8.5; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male