MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Swelling (2091); Burning Sensation (2146); Joint Swelling (2356)

Event Date 06/16/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06183, 0001825034-2017-06184, 0001825034-2017-06186, 0001825034-2017-06187.Concomitant medical products ¿ rgx 3 peg ser a patella 34mm catalog # 141357, lot # 305950, bmet regenx pri tib tray 79mm catalog # 141275, lot # 106510, biomet finned pri stem 40mm catalog # 141314, lot # 255870, vanguard cr por fmrl-lt 70 catalog # 183072 lot # 614310, stagraft dbm putty 5cc catalog # 92-2003, lot # 668040.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed,a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent left total knee arthroplasty and has experienced pain, immediate post operative pressure, loosening, burning sensation and swelling.A determination by physician as to whether the patient will need revision is to follow.There is no additional information at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Report was previously marked as a product problem in error.Reported event was unable to be confirmed due to limited investigative inputs provided by the customer.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.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.

• Brand Name: VANGUARD TIBIAL BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6787124
• MDR Text Key: 82448300
• Report Number: 0001825034-2017-06185
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-183560
• Device Lot Number: 598560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• 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 Age: 57 YR
• Patient Weight: 86