MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 12.0; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number	137621000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2018
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.(b)(4).
Event or Problem Description
Clinical adverse event received for foot drop.
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.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.Update 21-dec-2018: investigation re-opened upon receipt of additional information.The new information does not affect the previous investigation.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: CEMENTRALIZER 12.0
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8132959
• Report Number: 1818910-2018-77222
• Device Sequence Number: 11195576
• Product Code: LTO
• UDI-Device Identifier: 10603295034452
• UDI-Public: 10603295034452
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K871510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 137621000
• Device Lot Number: J04N00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: Other
• Patient Weight: 117