MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEMMED TIBIAL COMPONENT PRECOAT A/P WEDGED SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient received an initial left total knee arthroplasty on unknown date.Patient was first revised for loosening (product unknown).A second revision was performed approximately sixteen months after the first revision due to maltracking/component.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.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: radiographically, no obvious abnormality with regard to fit and alignment.Bone quality appears normal.Loosening, wear, radiolucency, or contributing factors are not confirmed radiographically.Tibial malrotation is not confirmed radiographically.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: preop diagnosis: aseptic loosening left knee replacement, spinal, midline incision, no infection, loose medial tibia plateau, oversized and loose femoral component, severe arthrofibrosis with 20-90 degree movement, 23 mm patella retained (unknown product), drain placed, weight bearing as tolerated.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
It was reported the patient had an initial left total knee arthroplasty on unknown date.A first revision was completed approximately 18 months prior to this report (product unknown).A second revision was reported due to maltracking/component malposition.The poly, stem extension, tibia, and patella were exchanged without complications.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT A/P WEDGED SIZE 4
• 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: 12605905
• Report Number: 0001822565-2021-02950
• Device Sequence Number: 7752985
• Product Code: JWH
• UDI-Device Identifier: 00889024220331
• UDI-Public: (01)00889024220331(17)280229(10)63901297
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 02/09/2022

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 Model Number: N/A
• Device Catalogue Number: 00598800400
• Device Lot Number: 63901297
• 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: 09/18/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• 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 Sex: Female
• Patient Weight: 80 KG