MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH; PLATE, FIXATION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Ulcer (2274)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00737, 0001822565-2019-00738, 0001822565-2019-00739, 0001822565-2019-00740, 0001822565-2019-00741, 0001822565-2019-007342, 0002648920-2019-00112, 0002648920-2019-00113, 0002648920-2019-00114.Udi# - (b)(4).Concomitant medical products: 3.5 mm locking screw with 2.7 mm head 12 mm length catalog 47235901238 lot 63327847; 3.5 mm locking screw with 2.7 mm head 14 mm length catalog 47235901438 lot 63610822; 2.7 mm locking screw 16 mm length catalog 47482801602 lot 63488874; 2.7 mm locking screw 16 mm length catalog 47482801602 lot 62545690; 2.7 mm locking screw 14 mm length catalog 47482801402 lot 63202015; 2.7 mm locking screw 14 mm length catalog 47482801402 lot 63849416; cortical bone screw self-tapping hex head 3.5 mm diameter 16 mm length catalog 47234801635 lot 63486170; cortical bone screw self-tapping hex head 3.5 mm diameter 14 mm length catalog 47234801435 lot 63486167; cortical bone screw self-tapping hex head 3.5 mm diameter 14 mm length catalog 47234801435 lot 63486167.Report source foreign - (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a plate and screws were removed approximately six months post implantation after an ulcer developed on the operative site.No additional information is available.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as no device was returned.Device history record (dhr) review identified no related manufacturing deviations or anomalies.Root cause is unknown.A batch examination of devices with related issues was performed.Following the removal of contamination on the devices, scanning electron microscopy identified isolated pitting corrosion at the screw plate interface constrained to the locking threads of the plate and the screws.The isolated pitting was not identified in other locations of the locking plates and screws, including the discolored areas surrounding the holes from which the tissue deposits were removed.Review of the related issue complaint device history records did not identify any related manufacturing deviations or anomalies that would have contributed to the reported event.The analysis confirms the device and it¿s materials are conforming to specifications.Root cause is unable to be determined at this time.The device labeling states that in-vivo implant corrosion is a possible adverse effect that may be anticipated as the device is implanted in a corrosive environment.Occurrence rates are within the expected rates therefore; no further action is needed at this time.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: DISTAL LATERAL FIBULAR PLATE LEFT 6 HOLES 106 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8348797
• MDR Text Key: 136505037
• Report Number: 0001822565-2019-00736
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K070906
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47235701806
• Device Lot Number: 63523235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• 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 Age: 70 YR