MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/08/2021
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 devised remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42558000301 63461852 partial femur cemented size 3 left medial.42538000401 63534512 partial tibial cemented size d left medial.Multiple mdrs have been submitted for this patient.Mdr 0001822565-2020-03165.Mdr 0001822565-2020-03166.
Event or Problem Description
A patient had a left persona partial knee in (b)(6) 2017.Subsequently, at two years, the patient is experiencing pain and rom limited mobility requiring steroid injection.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No devices or photos were received; therefore, the condition of the components is unknown.Review of the device history records identified no related deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint or part#42518200408, lot # 63424640 found no additional related issues for this item and the reported part and lot combination.Crf report provided by the patient and states that no intra-op complications were seen during the primary surgery.The follow up appointments after his surgery from three month visit to two year follow up state that patient had moderate pain and issues with range of motion.The patient was treated with steroid injection in (b)(6) 2019.This complaint is not confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Patient underwent revision left tka and components exchanged were femur, tibia, articular surface, and pfj.No operative report was provided.Health effect-impact code was updated to revision code.Root cause does not change from previous investigation.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 left initial total knee arthroplasty.Subsequently, 4 years post implantation, the patient reported severe pain.Patient was revised 5 months after the reported pain.The femur, tibia, articular surface, and pfj were exchanged.No operative report provided.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE D 8 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 10501529
• Report Number: 0001822565-2020-03167
• Device Sequence Number: 3182739
• Product Code: HSX
• UDI-Device Identifier: 00880304818057
• UDI-Public: (01)00880304818057
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2022

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 Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42518200408
• Device Lot Number: 63424640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/18/2020; 06/09/2022
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/22/2020; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White