MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ4; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	9611-64-000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > pc-(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 on (b)(6) 2015 the patient underwent the primary surgery with the pinnacle, the head, and the summit porocoat.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed that cup was loosened.Additionally, infection was suspected.Therefore, all the implants will be removed.On (b)(6) 2022 the cup and the stem will be removed.On (b)(6) 2022, if the patient is not infected and there is no problem, the implants will be replaced with other company¿s implants.No further information is available.
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: C-STEM SZ4
• 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15051649
• Report Number: 1818910-2022-13366
• Device Sequence Number: 14645623
• Product Code: JDI
• UDI-Device Identifier: 10603295235217
• UDI-Public: 10603295235217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9611-64-000
• Device Catalogue Number: 961164000
• Device Lot Number: 3053720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C-STEM PMMA END CAP; ELITE MODULAR HD 28MM -3; PINN MAR ETO LIP LNR 28IDX50OD
• Patient Sex: Female