MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C STEM VOID CENTALIZER 16 DM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number	9612-16-500
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2020
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.
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via bha.During the surgery, when the nurse tried to attach the centralizer to a stem, there was an abnormal noise and there was a crack in the centralizer.So, they could not use the centralizer.The sales rep didn't seem to think the nurse had applied excessive force.The surgery was completed without any surgical delay.There was no harms to the patient.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.B1 (adverse event) and b2 should not have been checked.

• Brand Name: C STEM VOID CENTALIZER 16 DM
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11177584
• Report Number: 1818910-2021-01242
• Device Sequence Number: 2947026
• Product Code: LZN
• UDI-Device Identifier: 10603295235873
• UDI-Public: 10603295235873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

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: 9612-16-500
• Device Catalogue Number: 961216500
• Device Lot Number: 8446445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/20/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 03/18/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 01/28/2021; 03/18/2021
• 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: C STEM VOID CENTALIZER 16 DM; UNKNOWN HIP FEMORAL STEM; C STEM VOID CENTALIZER 16 DM; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention