MAUDE Adverse Event Report: ZIMMER GMBH WAGNER CONE PROSTHESIS, IMPACTOR FOR TRIAL STEM; WAGNER CONE PROSTHESIS SYSTEM

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.(b)(4).(b)(4).

Event Description

It was reported that during procedure the surgeon noticed that the instruments were damaged and consequently difficult to use.This caused over 2 hours of delay, however the surgery was completed as planned.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: a cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2018-00712.

• Brand Name: WAGNER CONE PROSTHESIS, IMPACTOR FOR TRIAL STEM
• Type of Device: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7766410
• MDR Text Key: 116526512
• Report Number: 0009613350-2018-00712
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK113556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00569.010
• Device Lot Number: 16.333660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other