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

Model Number	141358
Medical Device Problem Codes	Fracture (1260); Biocompatibility (2886)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, approximately six (6) years post-implantation, the patient underwent revision surgery of the patella component as all three pegs on the device fractured off.During the revision surgery, a significant amount of blackened synovitis due to metallosis was noted and a synovectomy was performed.The patella component was revised however all other components remain implanted as no issues were noted.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: bmet regenx pri tib tray 75mm: catalog#141274, lot#970530; biomet finned pri stem 40mm: catalog#141314, lot#943170; vngd ps open por fmrl lt 70: catalog#184532, lot#427700; e1 vngd ps tib brg 71/75x10: catalog#ep-183640, lot#753860.Visual examination of the provided pictures identified sign of being in-vivo.Pegs were noted be fractured.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified that patient experienced pain and x-ray found fractured patella pegs.Upon opening, severe metallosis was found.A synovectomy was performed and the patella was replaced.All other components were stable and no damage were found.Investigation results concluded that the reported event was due to a a labeling and training deficiency as the surgical technique addendum for installation of the device failed to include guidance on depth line indication on the peg drill bit.The issue has been previously addressed and resolved through our capa process.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.

• Brand Name: RGX 3 PEG SER A PATELLA 37MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16700847
• Report Number: 0001825034-2023-00755
• Device Sequence Number: 17063125
• Product Code: JWH
• UDI-Device Identifier: 00880304506084
• UDI-Public: (01)00880304506084(17)200801(10)416530
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: 08/01/2020
• Device Model Number: 141358
• Device Catalogue Number: 141358
• Device Lot Number: 416530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male