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

Catalog Number 47235701706

Device Problem Corroded (1131)

Patient Problem Reaction (2414)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00680, 0001822565-2019-00681, 0001822565-2019-00682, 0001822565-2019-00683, 0001822565-2019-00684, 0001822565-2019-00685, 0001822565-2019-00686, 0001822565-2019-00687, 0001822565-2019-00688, 0001822565-2019-0069, 0001822565-2019-00690.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.Concomitant medical products: distal lateral fibular plate right 6 holes 106 mm length catalog# 47235701706, 2.7 mm locking screw 12 mm length catalog# 00482801202, 2.7 mm locking screw 14 mm length catalog# 00482801402 qty.4,.5 mm locking screw with 2.7 mm head 14 mm length catalog# 00235901438 qty.4, 3.5 mm locking screw with 2.7 mm head 18 mm length catalog# 00235901838.

Event Description

It was reported that a plate and screws were removed approximately four years post implantation after the patient was experiencing a reaction.Corrosion was noted on the explants.No additional information is available.

Manufacturer Narrative

No device was returned for examination.Review of device history records was not possible as the necessary product/lot code combination was not provided.A batch examination of devices related to this issue 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.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.

Event Description

No further information available at the time of this reporting.

• Brand Name: DISTAL LATERAL FIBULAR PLATE RIGHT 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: 8347962
• MDR Text Key: 136482919
• Report Number: 0001822565-2019-00680
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K063303
• 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: 09/03/2019

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 Catalogue Number: 47235701706
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA 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: 27 YR