MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR; PROSTHESIS, KNEE

Catalog Number 141275

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Cramp(s) (2193)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: regenerex series-a patella 3 peg, cat#: 141358 lot#: 232630, biomet knee system modular finned stem with screw, cat#: 141314 lot#: 584160, vanguard cr femoral component, cat#: 183070 lot#: 601330, vanguard tibial bearing cr lipped, cat#: ep-183560 lot#: 964280.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: 0001825034-2017-05065, 0001825034-2017-05066, 0001825034-2017-05067, 0001825034-2017-05068, 0001825034-2017-05069.Remains implanted.

Event Description

It was reported that the patient has occasional pain and cramping in the left knee.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Risks associated with the reported condition are addressed through the warnings in the package insert as a part of design control risk management.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: REGENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR
• 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: 6732660
• MDR Text Key: 80695789
• Report Number: 0001825034-2017-05067
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 141275
• Device Lot Number: 220440
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Weight: 118