MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ 2 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	9613-15-000
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via tha.During implanting, the surgeon assembled the stem and the centralizer, supplied cement to femur and tried to implant the stem appropriate timing, but he could not implant the stem properly depth although he impacted the stem a number of times strongly.The cement cured solidly in the setting of the insufficiency of the stem¿s implanting.The stem left several millimetres from the patient¿s femur.The patient¿s leg length did not suit, the surgeon explanted the stem and implanted another stem (manufactured by another company).The surgery was completed over 30 minutes delay.It was unknown why the stem was not inserted completely.The surgeon was skillful for the surgical technique.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H6 patient code: no code available (3191) used to capture the insufficient information.The previous reported device code fitting problem is being corrected to updated code which is inadequacy of device shape and/or size.

• Brand Name: C-STEM SZ 2 HIGH 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: 10301657
• Report Number: 1818910-2020-16353
• Device Sequence Number: 515600
• Product Code: JDI
• UDI-Device Identifier: 10603295236849
• UDI-Public: 10603295236849
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 9613-15-000
• Device Catalogue Number: 961315000
• Device Lot Number: D20020932
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C STEM VOID CENTALIZER 10 DM