MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 00830004500, tibial component size 5 right , lot # 63028696, item # 00830005500, talar component size 5 right, lot # 62898131, item # 00830005500, tm ankle tibial insert component size 5, lot # 62779362, item # 00235701706, distal lateral fibular plate right 6 holes 106 mm length, lot # 63301086.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 - 2019 - 02374, 0001822565 - 2019 - 02375, 0001822565 - 2019 - 02376, 0001822565 - 2019 - 02440.Patient not revised.

Event Description

It has been reported the patient underwent a total ankle arthroplasty.Subsequently, the patient experienced increased numbness in the plantar foot secondary to nerve compression two (2) years post initial surgery.No revision or further treatment performed at this time; however, it was noted that the event was resolved.No additional patient consequences were reported.

Manufacturer Narrative

It was identified this device did not cause or contribute to a serious injury or reportable malfunction.Please void this submission.

Event Description

It was identified this device did not cause or contribute to a serious injury or reportable malfunction.Please void this submission.

• Brand Name: UNKNOWN SCREW
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8691214
• MDR Text Key: 147726511
• Report Number: 0001822565-2019-02440
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• 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: 55 YR
• Patient Weight: 82