MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERIARTICULAR LOCKING PLATE FIBULA; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): a 00830001300, tm ankle talar component, 62416036n; 00830004300, tm ankle tibial base component, 77002854; 00830005300, tibial insert component, 62637225.Report source, foreign - the event occurred in (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: 0001822565 - 2018 - 01360, 0001822565 - 2018 - 01359.Remains implanted.

Event Description

It was reported that the patient underwent an initial ankle procedure.Subsequently, the patient underwent observation for heterotopic ossification treatment.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receipt of information and reassessment of the reported event, it was determined to be not reportable due to implants lack of contribution to the event.The initial report was forwarded in error and should be voided.

• Brand Name: PERIARTICULAR LOCKING PLATE FIBULA
• Type of Device: PROSTHESIS, ANKLE
• 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: 7322187
• MDR Text Key: 101834565
• Report Number: 0001822565-2018-01361
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00235701808
• Device Lot Number: 62745572
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2014
• 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; Other
• Patient Age: 69 YR
• Patient Weight: 95