MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RGX 3 PEG SER A PATELLA 34MM; PROSTHESIS, KNEE

Catalog Number 141357

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Pain (1994); Synovitis (2094); Reaction (2414); No Code Available (3191)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Concomitant medical products: catalog #: 184506, vgd ps open por fem rt 62.5, lot # 036910.Catalog #: 183640, vngd ps tib brg 10x71/75mm, lot # 013480.Catalog #: 141273, bmet regenx pri tib tray 71mm, lot # 277760.Catalog #: 141314, biomet finned pri stem 40mm, lot # 818090.Catalog #: 32-486265, 1/8 quick rel drl sterile 2pk, lot # 412170.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain.During the revision it was found that the patella pegs had worn down and that there was metallosis.The site was cleaned and a new palella button implanted.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.The x-rays provided were sent to an hcp for review.From the review, it was noted that no metallosis was found in the right knee.The only abnormalities of the right knee include osteopenia and small effusion.All the components were found intact and properly aligned.The additional review identified a patchy region of lucency proximal to the articular surface of the femoral hardware.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.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.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.This investigation remains closed.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.

Manufacturer Narrative

(b)(4).The reported event is confirmed via op notes.Review of op-notes identified grossly loose components as well as metal debris impregnated into the tibial bearing and the patella bone.Root cause remains undetermined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported patient underwent a right total knee arthroplasty revision approximately four (4) years post-operatively, due to pain and a loose patellar component.During the revision, metal debris was noted in the joint space, along with metallosis and synovitis, and some etching within the trochlea.The patella was removed and replaced with a cemented component.

Manufacturer Narrative

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.

Event Description

Medical records received further indicate that during the revision procedure the patella component was grossly loose.Furthermore, there was metallosis lining both the femoral and tibial components, but no gross loosening.There was metal debris impregnated within the tibial polyethylene liner and the patella button.There was etching as well within the femoral trochlea noted.The patella button was removed and replaced.

Manufacturer Narrative

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 3 PEG SER A PATELLA 34MM
• 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: 6698639
• MDR Text Key: 79544819
• Report Number: 0001825034-2017-04787
• 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: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 141357
• Device Lot Number: 165780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2013
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 78