MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 C STEM VOID CENTALIZER 10 DM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number	961210500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2017.It was reported that removal surgery was performed to explant the implants due to the infection (the date of removal was unknown).No further information was provided by the hospital.Doi: (b)(6) 2017; dor: unknown; unknown hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device(s) could not confirm the reported event.Product problem has not been identified.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: C STEM VOID CENTALIZER 10 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: 7544863
• Report Number: 1818910-2018-60592
• Device Sequence Number: 2029362
• Product Code: JDI
• UDI-Device Identifier: 10603295235682
• UDI-Public: 10603295235682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2018

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 Catalogue Number: 961210500
• Device Lot Number: 8588288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention