MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG LL 11X71; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item#: 195924; vgxp intlk femoral lt 70; lot#: 057900, item#: 195557; vgxp as e1 tib brg lm/rl 10x75; lot#:598480r, item#: 184786; series a pat thn 34 3 peg; lot#: 756240.Reported event was unable to be confirmed due to limited information received from the customer.This complaint was not confirmed.Device history record (dhr) reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.My mobility records were provided and reviewed by a healthcare professional.Review found patient was full weight bearing and no pain (b)(6) 2019.Mua performed on (b)(6) 2019 due to stiffness.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00769.0001825034-2020-00771.0001825034-2020-00772.

Event Description

It was reported the patient was experiencing stiffness and had a mua performed on his left knee approximately four months post-op.

Event Description

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

Manufacturer Narrative

Udi : (b)(4).This follow-up report is being submitted to relay additional information.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a healthcare professional.Review found patient had full extension with flexion limited to 90 degrees.Mua performed on (b)(6) 2019 due to stiffness and arthrofibrosis.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: VGXP XP E1 TIB BRG LL 11X71
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9959609
• MDR Text Key: 187688394
• Report Number: 0001825034-2020-01672
• Device Sequence Number: 1
• Product Code: MBH
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 195816
• Device Lot Number: 003840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 104