MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE E RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Thrombosis (2100); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01627, 0002648920-2019-00291, 0001822565-2019-01628, and 0002648920-2019-00292.Concomitant medical devices: stemmed tibial component precoat size 5, catalog#: 00598004701, lot#: 62316934; articular surface size green/c-h 10 mm height, catalog#: 00595204010, lot#: 62213181; all poly patella size 38 mm dia.Standard 9.5 mm thickness catalog#: 00597206538, lot#: 62038971; palacos r 1x40 single, catalog#: 00111214001, lot#: 74424287.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 right total knee arthroplasty.Subsequently, patient has been experiencing pain, limited range of motion, and difficulty ambulating.Patient also reported recurrent blood clots since the primary procedure.No revision procedure has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

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

• Brand Name: FEMORAL COMPONENT POROUS SIZE E RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8531579
• MDR Text Key: 142491265
• Report Number: 0001822565-2019-01627
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K031061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00597201502
• Device Lot Number: 62224036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• 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: 88