MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FIBULAR PLATE RIGHT 4 HOLES 80 MM LENGTH; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Tissue Damage (2104); Osteolysis (2377)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ event occurred in (b)(6).Customer has returned the product and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was implanted with a trauma plate to address a bone fracture.Osteolysis at the plate/screw interface was noted at the surgery to remove the plate after the bone had fully healed.A discharge at the wound site was noted and debrided, and the plate was routinely removed.Plate oxidation was noted upon removal.No further information is available.

Manufacturer Narrative

Udi# (b)(4).Visual examination of the returned product confirms device discoloration.Sem evaluation confirms the presence of foreign elements.Review of device history records identified no related manufacturing deviations or anomalies.The root cause 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.

Event Description

No further information available at the time of this reporting.

• Brand Name: DISTAL LATERAL FIBULAR PLATE RIGHT 4 HOLES 80 MM LENGTH
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7769316
• MDR Text Key: 116636699
• Report Number: 0001822565-2018-03232
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK070906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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: 00235701704
• Device Lot Number: 63351791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• 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: 52 YR
• Patient Weight: 57