MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL SCREW; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: polyax femoral plate, cat#: 814131112, lot#: dmhcyd.Polyax locking cortical screw 8 mm, cat#: 815045508, lot#: unk.Polyax locking cortical screw 10 mm, cat#: 815045510, lot#: unk.Polyax locking shaft screw 36 mm, cat#: 815045536, lot#: dpfc45.Polyax locking shaft screw 40 mm, cat#: 815045540, lot#: dpdcw6.Polyax screw 75 mm, cat#: 815355075, lot#: dpfdmz.Polyax screw 80 mm, cat#: 815355080, lot#: dpdcbv.Polyaxial screw 85mm, cat#: 815355085, lot#: dpcbtj.Cortical screw, cat#: 815745048, lot#: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.  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.Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-10362, 0001825034-2018-10363, 0001825034-2018-10364, 0001825034-2018-10365, 0001825034-2018-10366, 0001825034-2018-10367, 0001825034-2018-10368, 0001825034-2018-10370, 0001825034-2018-10371, 0001825034-2018-10373, 0001825034-2018-10374, 0001825034-2018-10375.

Event Description

It was reported that the patient underwent revision fifteen months after open reduction internal fixation of a periprosthetic fracture due to pain.It was further noted that the plate was prominent laterally, which was affecting range of motion of the knee.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The review of the operative report stated the patient had previously developed a periprostheic fracture.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.

• Brand Name: CORTICAL SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8051199
• MDR Text Key: 126544246
• Report Number: 0001825034-2018-10376
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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: 815745050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/05/2019
• 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
• Patient Weight: 92