MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF TWIN-PEG CMNTD FEM SM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-01277, 0001825034-2019-01278.Concomitant medical products: oxf uni tib tray sza rm/ll pma item# 154719 lot# 2154719, oxf anat brg rt sm size 3 pma item# 159568 lot# 428720.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.

Event Description

It was reported that patient underwent initial knee arthroplasty and subsequently the patient suffered pulmonary embolus.There is no additional information at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This mdr was submitted in error.The complaint has been reassigned to (b)(6).

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8439044
• MDR Text Key: 139411398
• Report Number: 0001825034-2019-01276
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 790270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86