MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET VANGUARD PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6) medical product: unknown biomet vanguard patella, cat#: unknown lot#: unknown, unknown biomet vanguard tibial tray, cat#: unknown lot#: unknown , unknown biomet vanguard femoral component, cat#: unknown lot#: unknown, unknown biomet vanguard tibial tray, cat#: unknown lot#: unknown , unknown biomet vanguard femoral component, cat#: unknown lot#: unknown, unknown biomet agc femoral component, cat#: unknown lot#: unknown, unknown biomet agc patella, cat#: unknown lot#: unknown, unknown biomet agc tibial tray, cat#: unknown lot#: unknown, unknown biomet agc femoral component, cat#: unknown lot#: unknown, unknown biomet agc patella, cat#: unknown lot#: unknown, unknown biomet agc tibial tray, cat#: unknown lot#: unknown, unknown cobalt cement, cat# unknown: lot#: unknown.Initial reporter: john b.Meding, kenneth e.Davis, merrill a.Ritter ¿ antibiotic bone cement and ultraviolet light use in total knee arthroplasty¿ open journal of orthopedics, 2016, 6, 283-293 the reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A 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 reports were filed for this event, please see associated reports: 0001825034-2017-06680, 0001825034-2017-06681, 0001825034-2017-06682, 0001825034-2017-06683, 0001825034-2017-06686, 0001825034-2017-06687, 0001825034-2017-06688, 0001825034-2017-06689, 0001825034-2017-06690, 0001825034-2017-06693, 0001825034-2017-06694.

Event Description

It was reported in a journal article groups 1-3 the kaplan-meier survivorship for reoperation for aseptic loosening of any component at five years was 0.9908 (0.9854, 0.9942), 0.9927 (0.9891,0.9952), and 0.9959 (0.9934, 0.9975), respectively (wilcoxon, p = 0.1315).The article did not report a whole number, however the group sizes were reported as group 1 (3105), group 2 (7537), group 3 (4573) attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequence was reported.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable.There are no allegations of failure of the device and the initial report was submitted in error.

• Brand Name: UNKNOWN BIOMET VANGUARD PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6816203
• MDR Text Key: 83479633
• Report Number: 0001825034-2017-06692
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention