MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona all poly patella, catalog # 42540000029, lot # 63586421.Unknown cement catalog # unknown lot # unknown.Multiple mdr reports were filled for this event: 0002648920-2022-00147.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported patient is experiencing pain and decreased activity post implantation.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - femur.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the allergic reaction is attributed to patient condition as the femoral component contains nickel.Per instructions for use 87-6203-757-23 rev d (zimmer gender solutions patello-femoral joint) associated with product item#: 00592601202, it states 'use only nexgen all-polyethylene, porous or augmentation patellas or gender solutions natural-knee flex all-polyethylene or metal-backed patellas with the zimmer gender solutions patello-femoral joint (pfj) prosthesis if resurfacing the patella.Patellas made for other systems may demonstrate excessive wear when used with these femoral components' it is unknown if this combination of products are contributing to the reported issue.A definitive root cause cannot be determined for the pain the patient experiences.Medical records review indicates on (b)(6) 2022 orthopedic analysis: highly reactive to nickel 9.2 and known stimulant (pha) 26.7.Highly reactive is above 8.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: CEMENTED PATELLO-FEMORAL TROCHLEA COMPONENT
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14928414
• Report Number: 0001822565-2022-01897
• Device Sequence Number: 6204835
• Product Code: JWH
• UDI-Device Identifier: 00889024205840
• UDI-Public: (01)00889024205840(17)270531(10)63675799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2022

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 Model Number: N/A
• Device Catalogue Number: 00592601202
• Device Lot Number: 63675799
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 11/03/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/03/2022; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2017
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female