MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ1 HI OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-14-070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/23/2021
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
Revision of a cstem/prostalac and cemented marathon cup from a first stage revision originally done on the (b)(6) 201 at flinders private hospital with surgeon for infection.Removal of implants and insertion of corail revision stem with acetabular components implanted.

• Brand Name: C-STEM AMT SZ1 HI OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12460164
• Report Number: 1818910-2021-19926
• Device Sequence Number: 11061432
• Product Code: KWA
• UDI-Device Identifier: 10603295060284
• UDI-Public: 10603295060284
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 1570-14-070
• Device Catalogue Number: 157014070
• Device Lot Number: D12030602A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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: ARTICULEZE M HEAD 36MM +12; C-STEM AMT SZ1 HI OFFSET; MARATHON XLPE CEMENT CUP 36/50; ARTICULEZE M HEAD 36MM +12; C-STEM AMT SZ1 HI OFFSET; MARATHON XLPE CEMENT CUP 36/50
• Outcome Attributed to Adverse Event: Required Intervention