MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZIMMER TRAUMA SCREW; FIXATION, PLATE

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

Patient Problem Death (1802)

Event Date 05/09/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Report source: journal: manara, j r; mathews, j a; sandhu, h s (2017).Cable plating with a single strut allograft in the treatment of periprosthetic fractures of the femur: cable plating and single strut allograft in periprosthetic femur fractures.Hip international, pgs 1-7.Doi: 10.1177/1120700018761519.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03557.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.[(b)(4)].Product not returned.

Event Description

It was reported in a journal article, that six (6) patients expired by the time the study was undertaken.Patients cause of death is not listed however; there is no mention it is product or procedure related and all six (6) patients had achieved fracture union at the final clinical follow up.

• Brand Name: UNKNOWN ZIMMER TRAUMA SCREW
• Type of Device: FIXATION, PLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8359301
• MDR Text Key: 136793186
• Report Number: 0001822565-2019-00802
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN ZIMMER TRAUMA PLATE
• Patient Outcome(s): Death