MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP INLK PRI TIB TRAY 65MM; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional concomitant medical products: unknown vangaurd tibial component catalog # unknown lot # unknown; unknown vangaurd articular surface catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation  has been completed, a follow-up mdr will be submitted.  multiple mdr reports were filled for this event: 0001825034-2018-00276, 0001825034-2018-00277.Remains implanted.

Event Description

It is reported that the patient underwent a knee arthroplasty.Subsequently, the patient required injections to treat post-operative pain.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: 195909, vgxp intlk femoral rt 62.5, 029390; 195772, vgxp xp e1 tib brg rl 9x63, 526870; 195842, vgxp xp e1 tib brg rm 9x63, 335190.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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

It was reported that the patient experienced a fracture of the anterior bony island on an unknown date that required re-fixation using ethibond.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.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: VGXP XP INLK PRI TIB TRAY 65MM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7189697
• MDR Text Key: 97300704
• Report Number: 0001825034-2018-00275
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK132873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 195752
• Device Lot Number: 450410
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 61