MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RL 10X71; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-05362, 0001825034-2019-05365.Concomitant medical products: vgxp intlk femoral rt 67.5 , item# 195911, lot# 070690.Vgxp xp e1 tib brg rm 10x71, item# 195850, lot# 109960.Vgxp xp inlk pri tib tray 75mm, item# 195757, lot# 111730.Series a pat thn 34 3 peg, item# 184786, lot# 524530.Unknown palacos cement.Report source - united kingdom.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 a patient reported a decrease in flexion and increase in pain and stiffness approximately one-year post implantation.No revision or intervention has been noted at this time.There is no additional information at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No devices were received; therefore, the condition of the components is unknown.Primary operative notes do not suggest any intra operative complications.Office notes from six week follow up to one year confirm patient had pain, stiffness and a decrease in flexion.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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.

Event Description

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

• Brand Name: VGXP XP E1 TIB BRG RL 10X71
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9382667
• MDR Text Key: 168194962
• Report Number: 0001825034-2019-05366
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00880304552388
• UDI-Public: (01)00880304552388
• Combination Product (y/n): N
• PMA/PMN Number: K132873
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2019
• Device Model Number: N/A
• Device Catalogue Number: 195780
• Device Lot Number: 476510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• 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: 76