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

Model Number	L98114
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11123630
• Report Number: 1818910-2021-00436
• Device Sequence Number: 19758178
• Product Code: LWJ
• UDI-Device Identifier: 10603295262428
• UDI-Public: 10603295262428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: L98114
• Device Catalogue Number: L98114
• Device Lot Number: 5331320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 90