MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS HIP

Catalog Number UNKNOWN HEAD

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown cup, pn unknown, ln unknown.Report source- (b)(6).Multiple mdr reports were filed for this event.Please see reports: 0001825034-2018-09092.The reported event was identified during review of a journal article.High early major complication rate after revision for mechanically assisted crevice corrosion in metal-on-polyethylene total hip arthroplasty.The bone and joint journal bone joint j 2018;100-b:720¿4.

Event Description

It was reported in a journal article patient experienced a revision due to swelling, in-vivo implant corrosion and adverse local tissue response on an unknown date.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2018-05345.

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7905941
• MDR Text Key: 121598974
• Report Number: 0001825034-2018-09091
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN HEAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention