MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Physical Asymmetry (4573)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had bilateral hips done in (b)(6) 2020.The patient reported that they have leg length discrepancy of 1 inch, inability to walk 50 yards, extreme pain in both hips and legs.The patient reports that they can "feel the coldness" of the implants and can "feel the separation" of the implants.The patient reports that due to the complications in surgery, their legs are "wasting away" and that their "body is not accepting the implants" as they are porous coated.The patient wants their implants removed.It should be noted that there has been invasive treatment or revision at this time.Doi: unknown.Doe: unknown.Affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed, as the required product/lot number was not provided to complete the evaluation.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: the device lot number is unknown.Therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.H10 additional narrative: added: e1 (hospital).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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: 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
Medical records were received: on (b)(6) 2009, the patient had an open arthrotomy of the right hip arthroplasty to address severe degenerative arthritis of the right hip.Depuy components were implanted during this procedure.On (b)(6) 2024, the patient had a right hip revision.Doi: (b)(6) 2009.Doe: (b)(6) 2024.Right hip.

• Brand Name: CORAIL2 STD SIZE 12
• 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: 19299039
• Report Number: 1818910-2024-10465
• Device Sequence Number: 6711289
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: 10603295168782
• 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: 2009
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/01/2014
• Device Catalogue Number: 3L92512
• Device Lot Number: 2825168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 05/21/2024; 06/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/14/2024; 05/24/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2009
• 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: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 79 KG