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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity and/or excessive weight." number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma non-union or excessive weight." number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain." expected, not yet received.

Event Description

Patient underwent a right knee revision procedure approximately two years post-implantation due to pain, loosening and the pegs of the patella shearing off.

Event Description

Patient reported undergoing a right knee revision procedure approximately 23 months post-implantation due to the patella component allegedly fracturing and disassociating from the pegs.A review of invoice history confirms patella button was removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.The revision operative report noted pain and discomfort of the patient and further mentioned that the patella component was loose and that the pegs had sheared from the metal backing; all fragments and debris were removed.

Manufacturer Narrative

Concomitant medical products: bmet regenx pri tib tray 67mm catalog # 141272 l# 052730; e1 vngd cr tib brg 63/67x12 catalog # ep-183422 l# 390350; vanguard cr por fem-rt 60 catalog # 183044 l# 327880; modular splined stem 40mm catalog # 141369 l# 948710.The reported was confirmed by medical records received and product returned.Visual inspection found the patella pegs have fractured off and into multiple pieces.The sem analysis report for the regenerex patella component revealed that the surfaces were smeared, possibly due to post fracture damage, and there were no fracture characteristics identified on the surfaces.Sem micrographs also revealed smeared indications and no fracture features.Therefore, it is inconclusive to determine the mode of fracture and to understand how the patella pegs fractured.Review of the complaint history determined that no further action is required.The root cause of the patella peg fracture was determined to be a labeling and training deficiency as the surgical technique addendum for installation of regenerex patella failed to include guidance on depth line indication on the peg drill bit.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: RGX 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5747707
• MDR Text Key: 48099138
• Report Number: 0001825034-2016-02270
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 101710
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2014
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 86