MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C STEM VOID CENTALIZER 12 DM; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number	961212500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (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
Revision thr due to periprosthetic fracture, dr (b)(6), (b)(6) hospital (b)(6) 2017.Patient underwent primary thr on (b)(6) 2017 -dr (b)(6), (b)(6).Patient was doing well until a fall 2 days ago.X rays indicate a peri prosthetic fracture.The femoral stem and cement was removed and a reclaim revision stem implanted.The pinnacle cup and liner were left in situ.The fracture sight was circlaged with a number of cables.Male patient initials (b)(6), aged (b)(6) years, dob (b)(6).Doi; (b)(6) 2017; dor: (b)(6) 2017; unknown affected side.
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.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
• 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: 7178328
• Report Number: 1818910-2018-50807
• Device Sequence Number: 11012377
• Product Code: JDI
• UDI-Device Identifier: 10603295235736
• UDI-Public: 10603295235736
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K013350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 961212500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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
• Patient Age: 71 YR