MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL REVISION STEM HO 14; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number L98114

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the stem has subsided and was loose.Original surgery was (b)(6) 2020 and 1st revision was (b)(6) 2020.No surgical delay reported.No additional information is available.Doi: (b)(6) 2020, dor: (b)(6) 2020, left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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.

• Brand Name: CORAIL REVISION STEM HO 14
• Type of Device: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11123630
• MDR Text Key: 225284956
• Report Number: 1818910-2021-00436
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295262428
• UDI-Public: 10603295262428
• Combination Product (y/n): N
• PMA/PMN Number: K093736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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
• Device Operator: Health Professional
• Device Model Number: L98114
• Device Catalogue Number: L98114
• Device Lot Number: 5331320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5; ALTRX NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5
• Patient Outcome(s): Required Intervention
• Patient Weight: 90