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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: therapy date: unknown.141272 - bmet regenx pri tib tray 67mm - 767890; 183066 - vanguard cr por fmrl-lt 62.5 - 218760; 141314 - biomet finned pri stem 40mm - 717790; 183422 - vngd cr tib brg 12x63/67 - 568840.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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 that the patient underwent an initial left knee arthroplasty.Subsequently, the patient is being considered for a revision of the patella due to pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
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.Bone scan results state mild to moderate hyperemia involving left knee in the region of the patella, increased activity in all 3 phases involving left patella.No definitive diagnosis provided.Office visit notes state that patient had worsening pain.X-ray review states 'stable appearing left total knee arthroplasty with regards to femoral and tibial components.On the sunrise view some question of interval change and hardware failure of left patella with shift of the plastic button', plan for revision of patellar component.No definitive diagnosis provided, surgeon will assess during revision.Root cause cannot be determined.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.

• Brand Name: RGX 3 PEG SER A PATELLA 34MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10021885
• Report Number: 0001825034-2020-01907
• Device Sequence Number: 14232268
• Product Code: MBH
• UDI-Device Identifier: 00880304554429
• UDI-Public: 00880304554429
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K083782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: N/A
• Device Catalogue Number: 141357
• Device Lot Number: 125490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: Other