MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X71/75; PROSTHESIS, KNEE

Model Number N/A

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

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

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: vanguard cr ilok femur-lt 67.5, catalog: 183030, lot: j3953848; polished finned tibial tray 71mm, catalog: 141253, lot: 2014070113; series a pat std 31 3 peg 184764, lot: 426800.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02347.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 the patient underwent a manipulation under anesthesia approximately one month post total knee arthroplasty due to unexplained pain and limited range of motion.No further intervention was reported.

Event Description

No additional information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were reviewed and identified limited flexion and extension as well as unexplained pain and confirmed the manipulation under anesthesia.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD CR TIB BRG 10X71/75
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8651211
• MDR Text Key: 146406331
• Report Number: 0001825034-2019-02348
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 183440
• Device Lot Number: 630980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 75