MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION; 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).D4 - two device ids were provided by the reporter; of these, only one (1) was reported to have metal allergy.It is unknown which exact device encountered this issue, it is one of the following: item#: 42542006701, lot#: 64960941, manufacture date: mar 29, 2021, sterile expiry date: mar 22, 2031, udi: (b)(4), 510k: k191625 pro code: jwh.Or item#: 42545000511 lot#: 64815927, manufacture date: oct 20, 2020, sterile expiry date: sep 30, 2030, udi: (b)(4), 510k: k191625 pro code: jwh.D10 - medical product: femoral central cone catalog # 42545001012 lot# 64700341; stem extension tapered cemented catalog # 4256007514 lot# 65032365; femur cemented standard catalog # 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 # 66056768 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, 0001822565-2023-01301, 0001822565-2023-01314.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 at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d4, g3, g4, g6, h1, h2, h3, h4, h6, h10.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION
• 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: 16938319
• Report Number: 0001822565-2023-01300
• Device Sequence Number: 17679324
• Product Code: JWH
• UDI-Device Identifier: 00889024562783
• UDI-Public: (01)00889024562783(17)310322(10)64960941
• 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: 42542006701
• Device Lot Number: 64960941
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female