MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RGX 3 PEG SER A PATELLA 31MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical devices: vngd ps open por fmrl rt 67.5 catalog#: 184510 lot#: 184500.E1 vngd ps tib brg 71/75x12 catalog#: ep-183642 lot#: 004570.Bmet regenx pri tib tray 71mm catalog#: 141273 lot#: 848410.Biomet finned pri stem 40mm catalog#: 141314 lot#: 943120.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a right knee revision nearly five years post-implantation due to patella implant fracture.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No devices or photos were received; therefore, the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.Primary operative notes does not suggest any intra operative complications.Revision operative notes state that one of the patella peg was fractured, 2nd one was half broken and third one is intact.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.Actions were initiated to address the issue of risk of fracture was not included in the rmf.The product has since been recalled.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Update: b4, d9, g3, g6, h2, h3, and h10.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device found signs of being implanted with wear, discoloration, foreign material, and one of the posts have fractured off.No update to root cause.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: RGX 3 PEG SER A PATELLA 31MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10976524
• Report Number: 0001825034-2020-04292
• Device Sequence Number: 11560722
• Product Code: MBH
• UDI-Device Identifier: 00880304554412
• UDI-Public: (01)00880304554412(17)200622(10)328680
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2020
• Device Model Number: N/A
• Device Catalogue Number: 141356
• Device Lot Number: 328680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 02/26/2021; 10/04/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/15/2021; 03/25/2021; 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention