MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: femoral central cone catalog#: 42545001012, lot#: 64700341.Tibia fixed cemented stem extension catalog#: 42542006701, lot#: 64960941.Stem extension tapered cemented catalog#: 4256007514, lot#: 65032365.Femur cemented item#: 42504605401 lot#: 65046024.Stem extension catalog#: 42560007514, lot#: 65033946.Tibia central core catalog#: 42545000511, lot#: 64815927.Femur cemented catalog#: 42504605411, lot#: 65046008.Stem extension catalog#: 42560113510, lot#: 64911578.Articular surface catalog#: 42512600414, lot#: 65321527.Cable cerclage cable catalog#: 00223200418, lot#; 65240317.Cable cerclage cable catalog#: 00223200418, lot#: 65240311.Palacos r+g fast catalog#: 6605676,8 lot#: 99571117.Palacos r+g fast catalog#: 66056768, lot # 99571117.Palacos r+g fast catalog#: 66056768, lot # 99571117.Female hex screw catalog#: 42509902525, lot # 65259825.G2: australia.H3: 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.Multiple mdr reports were filled for this event: 0001822565-2023-01299, 0001822565-2023-01300, 0001822565-2023-01301.H3 other text : remains implanted.
Event or Problem Description
It was reported patient is experiencing allergy to metal eight months 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 submitted to relay additional information.H6: mechanical (04)- femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.Multiple mdr reports were filled for this event: 0001822565-2023-02550, 0001822565-2023-02551, 0001822565-2023-02552.

• Brand Name: FEMUR CEMENTED
• 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: 17586415
• Report Number: 0001822565-2023-02176
• Device Sequence Number: 3627068
• Product Code: JWH
• UDI-Device Identifier: 00889024562653
• UDI-Public: (01)00889024562653(17)310512(10)65046008
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42504605411
• Device Lot Number: 65046008
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female