MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT SZ12 STD COL; CORAIL IMPLANT : HIP FEMORAL STEM

Model Number	L971212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2021
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
Patient presented in surgeons office with painful left hip and redness.Surgeon ordered serum testing for infection and it came back positive.Surgeon elected to perform a single stage revision on (b)(6) at (b)(6) hospital.Surgeon removed primary components using depuy standard instruments.Surgeon then proceeded with his protocol for infection treatment.Surgeon then elected to implant new components and continue to treat the patient for infection.No components broke during the case.There was no mention by anyone that the components contributed to the event.There were no time delays.Index surgery happened on (b)(6) 2021 at (b)(6) hospital by the surgeon.
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 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: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: CORAIL AMT SZ12 STD COL
• Common Device Name: CORAIL IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12042697
• Report Number: 1818910-2021-13300
• Device Sequence Number: 19834517
• Product Code: LZO
• UDI-Device Identifier: 10603295478638
• UDI-Public: 10603295478638
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: L971212
• Device Catalogue Number: L971212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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 +4 NEUT 32IDX50OD.; CORAIL AMT SZ12 STD COL.; DELTA CER HEAD 12/14 32MM +1.; PINN CAN BONE SCREW 6.5MMX40MM.; PINNACLE SECTOR II CUP 50MM.; ALTRX +4 NEUT 32IDX50OD; CORAIL AMT SZ12 STD COL; DELTA CER HEAD 12/14 32MM +1; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR