MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 6; CORAIL AMT CEMENTLESS IMPLANT : HIP IMPLANTS

Model Number	L20106
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 patient was revised due to pain.Femoral stem was slightly loose and removed.Revised with a biomet taper loc stem.Doi: unknown (approximately 11 years ago).Dor: (b)(6) 2020; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.Three provided patient x-rays have been reviewed.It was not possible to confirm a loosening event with the provided images.Nothing indicative of a product problem is identified.The information received will be retained for potential series investigations if triggered by trend analysis 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.

• Brand Name: CORAIL2 STD SIZE 6
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP IMPLANTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10734084
• Report Number: 1818910-2020-23294
• Device Sequence Number: 14316871
• Product Code: KWA
• UDI-Device Identifier: 10603295257998
• UDI-Public: 10603295257998
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/12/2020

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: L20106
• Device Catalogue Number: L20106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: ARTICULEZE M HEAD 36MM -2; ARTICULEZE M HEAD 36MM -2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR