MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PS OPEN INTL FEMORAL RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Information (3190)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet cc cruciate tray 67mm catalog # 141232 lot # unknown, vngd ps tib brg 14x63/67mm catalog # 183624 lot # unknown, series a pat thn 28 3 peg catalog # 184782 lot # unknown.Customer has indicated that the product will not be returned because product location is unknown.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: 0001825034-2020-00801.Product location is unknown.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to loosening of femoral and tibial prosthesis.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

Concomitant medical products: cobalt mv bone cement 40gm b catalog # 402438 lot # 863050.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) 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.Multiple mdr: 0001825034 - 2020 - 01675.

Event Description

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

Event Description

From additional information received, it was reported that patient was revised due to pain and loosening of the tibial and femoral components.During the revision, the tibial and femoral components were easily removed and replaced with competitor product.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Reported event was confirmed by review of medical records provided.Revision operative notes indicates that tibial and femoral components were easily removed and initial patellar component remained intact.Additional information does not affect the root cause.

Event Description

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

Manufacturer Narrative

Medical product: biomet cc cruciate tray 67mm catalog # 141232 lot # j3118728.Vngd ps tib brg 14x63/67mm catalog # 183624 lot # 613560.Series a pat thn 28 3 peg catalog # 184782 lot # 477800.Optivac total hip kit catalog # 418000 lot # 0000823738.Cobalt mv bone cement 40gm b catalog # 402438 lot # 863050.

• Brand Name: VANGUARD PS OPEN INTL FEMORAL RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9739338
• MDR Text Key: 189310497
• Report Number: 0001825034-2020-00800
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 183106
• Device Lot Number: 061960
• 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): Hospitalization; Required Intervention