MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/08/2021

Event Type  Injury  

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.42518200408, 63424640, partial articular surface left medial size d 8.Multiple mdrs have been submitted for this patient: mdr 0001822565-2020-03165, mdr 0001822565-2020-03167.

Event 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.

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 history for part#42538000401, lot # 63534512 identified two additional similar for the reported item and no additional complaints for part and lot combinations.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.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.

Event Description

No further event information available at the time of this report.

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 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 TIBIAL CEMENTED SIZE D LEFT MEDIAL
• Type of Device: 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: 10501462
• MDR Text Key: 205899730
• Report Number: 0001822565-2020-03166
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812666
• UDI-Public: (01)00880304812666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000401
• Device Lot Number: 63534512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White