MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION SIZE F RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that: today we revised an rhk femur as it was explained by the operating surgeon that the patient's right knee joint line was out of alignment.It was therefore decided to revise the femur and implant the same size femur (size f) with a longer stem (200mm offset stem) and distal augments to distalise the femur are correct the joint line.No delay.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).Report source: south africa.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check as the product information for the articular surface is unknown.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: both images are undated and a surgical drain is present.For both images the right knee arthroplasty implants are anatomically aligned.There is no acute abnormality.Overall implant fit and alignment are maintained on both images.Bone quality appears mildly osteopenic.Complaint is not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products: 00597206538, all poly petella standard cemented size 38 mm diameter 9.5 mm thickness, lot#: 63555317.00801102024, allen medullary cement plugs 1-24 mm diameter flange/12 mm diameter, lot#: 64563093.00588000500, tibial component precoat size 5, lot#: 64752886.00598801215, stem extension straight 15mm dia x 30mm length(combined length 75mm), lot#: 64597236.00588000510, tibial full block augment precoat size 5 10 mm thickness, lot#: 64558824.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.

• Brand Name: FEMORAL COMPONENT OPTION SIZE F RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14704763
• Report Number: 0001822565-2022-00707
• Device Sequence Number: 14019388
• Product Code: KRO
• UDI-Device Identifier: 00889024199170
• UDI-Public: (01)00889024199170(17)250228(10)64558824
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 0588001602
• Device Lot Number: 64558824
• 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: 01/31/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male