MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 C STEM VOID CENTALIZER 12 DM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number 961212500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pain (1994)

Event Type  Death  

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.Date of death is currently unknown.Initial reporter occupation: non-healthcare professional "patient family member".

Event Description

Patient communication received.A daughter of a patient from (b)(6), called up regarding the hip replacement compensation, in reference to the news she read in the newspaper.She said that her mother had undergone a surgery of total hip replacement in the year 2014 at a hospital in (b)(6), and in (b)(6) 2015 her mother passed away.Thus, she wants to know the procedure to claim the compensation amount.

Manufacturer Narrative

Product complaint : (b)(4).Investigation summary : no device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: C STEM VOID CENTALIZER 12 DM
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8314625
• MDR Text Key: 135347033
• Report Number: 1818910-2019-83467
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295235736
• UDI-Public: 10603295235736
• Combination Product (y/n): N
• PMA/PMN Number: K013350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 961212500
• Device Lot Number: 4727177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other