MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX SERIES A 3 PEG PATELLA 37MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vngd ps open por fmrl rt 72.5, item# 184513, lot# 254620.Biomet finned pri stem 40mm, item# 141314, lot# 782720.Bmet regenx pri tib tray 79mm, item# 141275, lot# 740880.E1 vngd ps tib brg 79/83x10, item# ep-183660, lot# 288270.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right knee arthroplasty revision approximately 2 years and 9 months¿ post implantation due to patellar implant fracture.Initial operative notes state that the patellar component was press-fit into place and the knee was brought to full range of motion with good stability.Revision operative notes state that there was blackening of the synovium and the patellar component was grossly loose.When the patellar component was pulled out, all three (3) pegs were identified to have fractured off.A new patella was implanted without further complications.There is no additional information at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The complaint is considered confirmed as an image of the explanted device was provided.Photograph of the returned device shows all three pegs of the patella have fractured.Photograph also shows blackened tissue that was taken out during the surgery.Primary operative notes do not suggest any intra operative complications.Revision operative notes state that patella was noted to be grossly loose and all the three pegs had broken off.Also, blackening of the synovium was noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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.

Event Description

No further event information available at the time of this report.

Event Description

It was reported that a patient was revised approximately two years and nine months post implantation due to failure of the patella, fracture of pegs on patella, pain, metallosis, and loosening.Revision operative notes state that there was blackening of the synovium and the patellar component was grossly loose.When the patellar component was pulled out, all three pegs were identified to have fractured off.A new patella was implanted without further complications.Attempts to obtain additional information have been made; however, no more information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

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: REGENEREX SERIES A 3 PEG PATELLA 37MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8749489
• MDR Text Key: 149679115
• Report Number: 0001825034-2019-02720
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K083782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 141358
• Device Lot Number: 778870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: HHE 2017-15
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention