MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42502806002, femur, lot # 64278763, 42530006702, tibia, lot # 64102955, 00587806535, patella, lot # 6425270.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00526, 0001822565 - 2020 - 00527.

Event Description

It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee.Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

The reported event was able to be confirmed by review of the provided medical records.During the one-month post op visit, pain, swelling, and stiffness were reported.Thus, a manipulation under anesthesia was performed with injection of marcaine and depomedrol to the right knee.Review of the device history records did not identify any deviations or anomalies during manufacturing related to the reported event.Review of the instructions for use of the persona knee system identified that pain, stiffness, and limited range of motion are potential known adverse effects of the tka.However, a definitive root cause cannot be determined.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: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9681151
• MDR Text Key: 178121626
• Report Number: 3007963827-2020-00043
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468115
• UDI-Public: (01)00889024468115
• Combination Product (y/n): N
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522100412
• Device Lot Number: 63811402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 55