MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number 00596203210

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001822565 -2019 -01194, 0001822565 -2019 -01195.Udi: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the patient reported pain, swelling, and decreased rom leading to a manipulation under anesthesia 6 weeks post initial right side implantation.Arthrofibrosis was contributing factor to this event.No further information is available at this time.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Initial op notes demonstrated that the patient had right tka due to osteoarthritis.Op notes dated (b)(6) 2017 demonstrated that the patient underwent a manipulation under anesthesia due to pain, swelling and decreased rom due to arthrofibrosis.Review of the x-rays identified no evidence for hardware failure or loosening.Complaint confirmed with op notes.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.

• Brand Name: ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8433343
• MDR Text Key: 139224438
• Report Number: 0001822565-2019-01194
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K042271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 00596203210
• Device Lot Number: 63530962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00596801552 LPS FLEX FEMORAL, LOT : 63668764; 00596801552 LPS FLEX FEMORAL, LOT : 63668764
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 67