MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5MM LK SCR 2.7MM16MM LE; PLATE, FIXATION

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Bone Fracture(s) (1870); Swelling (2091)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 47235901438, periarticular locking scrs st, 63138409; 47235901438, periarticular locking scrs st, 63138409; 47482801402, 2.7mm univ locking screws ster, 63138387; 47235701706, periarticular lkng plt fib st, 63185712; 47482801202, 2.7 mm locking screw 12 mm length, 63088386; 47482801602, 2.7mm locking screw 16mm long, 63094793.Report source, foreign - the event occurred in the (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports.

Event Description

It was reported that the patient underwent a right ankle orif (open reduction and internal fixation) due to an ankle fracture.Subsequently, the patient was revised due to redness and swelling, and the explanted products showed signs of corrosion.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further information has been made available at the time of this reporting.

Manufacturer Narrative

The initial entry for this submission had an incorrect date in the received by the manufacturer.The date the information was identified was july 12, 2019.

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.

Event Description

No further information available at the time of this reporting.

• Brand Name: 3.5MM LK SCR 2.7MM16MM LE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8784683
• MDR Text Key: 150831255
• Report Number: 0001822565-2019-02709
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K132239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• 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: 00235901638
• Device Lot Number: 63234409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR