MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL REVISION STEM STD 10; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number L98010

Device Problems Osseointegration Problem (3003); Migration (4003)

Patient Problems Fall (1848); Inadequate Osseointegration (2646)

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that the patient received a tha (b)(6) 2024 after a nail removal that cut through the femoral head.Patient fell on 2/16 and dislocated her hip.They were not able to reduce in the ed so brought back to operating room.Appeared stem subsided from fall and was loose.Stem and dual mobility was revised to cemented endurance stem and constrained liner.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side : right hip.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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 records evaluation (mre) was not performed.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.

• Brand Name: CORAIL REVISION STEM STD 10
• Type of Device: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18893539
• MDR Text Key: 337528867
• Report Number: 1818910-2024-05690
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295262299
• UDI-Public: 10603295262299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L98010
• Device Lot Number: 5510340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BI MENTUM ALTRX LNR 45 22; CREATED IN ERROR; PINNACLE DM LINER 52_45
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female