MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET REGENEREX TIBIAL COMPONENTS; PROSTHESIS, KNEE

Catalog Number 141272

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant products: biomet mck maximum congruent knee, cat#: 141314 lot#: 104580; biomet vanguard complete knee system, cat#: 183044 lot#: 802440; biomet vanguard complete knee system, cat#: 183420 lot#: 199130; biomet vanguard patella components, cat#: 184762 lot# 549890.Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.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: 0001825034-2017-04864, 0001825034-2017-04866, 0001825034-2017-04867, 0001825034-2017-04874, 0001825034-2017-04889.

Event Description

It was reported that the patient is experiencing a fever, pain and swelling immediately following a knee procedure.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends 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: BIOMET REGENEREX TIBIAL COMPONENTS
• 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: 6709878
• MDR Text Key: 79894164
• Report Number: 0001825034-2017-04889
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 141272
• Device Lot Number: 127720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other