MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT COLLAR SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92500
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Discomfort (2330)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After the review of medical records, operative notes reported pain.X-ray showed obvious subsidence of the implant, implant loosening and infection may already be present.The surgeon was able to externally rotate some of the sleeve scar tissue.Clinic visits reported discomfort and movement impairment.Doi: (b)(6) 2007 dor: (b)(6) 2022 right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer 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.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 performed.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.
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 that 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 that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Updated event description : litigation complaint received.The patient suffered right-sided groin pain which wraps around the buttock.Her pain is worse with pivoting motions.Also reports start-up pain.She fell down a flight of stairs in november when her leg gave out.Severe increasing right hip and thigh pain that came on very quickly.Acute fracture but certainly had an impending fracture.

• Brand Name: CORAIL AMT COLLAR SIZE 10
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18933899
• Report Number: 1818910-2024-06097
• Device Sequence Number: 4540696
• Product Code: LZO
• UDI-Device Identifier: 10603295168669
• UDI-Public: (01)10603295168669(17)40667(10)2146638
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/19/2024

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: 05/04/2011
• Device Catalogue Number: 3L92500
• Device Lot Number: 2146638
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 09/30/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/03/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2006
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 86 KG