MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION OFFSET SPLINED UNCEMENTED; 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 products: femur cemented standard catalog # 42504607001 lot # 64867256; tibia fixed cemented stem extension catalog # 42542007501 lot # 64649521; articular surface fixed bearing constrained condylar knee (cck) catalog # 42512800810 lot # 64277829; stem extension offset splined uncemented catalog # 42560613515 lot # 64783591; femoral distal augment cemented catalog # 42556607005 lot # 64769970; tibial central cone catalog # 42545000512 lot # 64680479; articular surface locking screw and insert kit catalog # 42510033056 lot # 64500615.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: 0001822565-2022-02633; 0001822565-2022-02645; 0001822565-2022-02646; 0001822565-2022-02647; 0001822565-2022-02648; 0001822565-2022-02649; 0001822565-2022-02651.
Event or Problem Description
It was reported patient is experiencing pain approximately 18 months post implantation.Attempt for further information has been made, but no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Corrected: d4 (udi number).No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Only initial medical records were provided and reviewed by a health care professional.Review of the available records identified the following no intra ops complication during the surgery.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert, pain is known adverse effect of the system.If any further information is which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04)-stem.

• Brand Name: STEM EXTENSION OFFSET SPLINED UNCEMENTED
• 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: 15411098
• Report Number: 0001822565-2022-02650
• Device Sequence Number: 17880676
• Product Code: JWH
• UDI-Device Identifier: 00887868250279
• UDI-Public: (01)00887868250279(17)300725(10)64799559
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 12/02/2022

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: 42560613513
• Device Lot Number: 64799559
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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: Male
• Patient Weight: 89 KG