MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZPLP FIBULAR PLATE; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-01389 medical product: unknown screws.Report source: (b)(6).No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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.Reference: yeo, e.D., kim, h.J., cho, w.I., & lee, y.K.(2015).A specialized fibular locking plate for lateral malleolar fractures.The journal of foot and ankle surgery, 54(6), 1067¿1071.Https://doi.Org/10.1053/j.Jfas.2015.06.002.

Event Description

It was reported in a journal article that a study reported that a patient who had a left trimalleolar fracture developed metallosis.The metallosis developed at the second screw in the proximal part of the locking plate.No preoperative clinical symptoms or a specific medical prognosis were obtained from the patient which was only confirmed during device removal with marginal excision.

• Brand Name: UNKNOWN ZPLP FIBULAR PLATE
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11934677
• MDR Text Key: 254259165
• Report Number: 0001822565-2021-01388
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR