MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXFORD FIXED LATERAL TIBIAL BEARING E3 RIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices - oxford twin-peg cemented femoral component catalog #: 161469 lot #: 669690.The complainant 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.Investigation incomplete.

Event Description

It was reported that the patient underwent a right knee manipulation under anesthesia to address arthrofibrosis approximately two (2) months following knee arthroplasty.Following the manipulation, the patient's range of motion improved and the patient was able to resume regular activities.Initial operative notes noted no intraoperative complications.Manipulation operative notes noted that flexion manipulation was performed and careful breaking of scar tissue adhesions was audible.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was confirmed through review of medical records.Manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.Manipulation under anesthesia is used to treat and resolve arthrofibrosis, or scar tissue.This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The root cause of the reported event cannot be traced to the device.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

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

• Brand Name: OXFORD FIXED LATERAL TIBIAL BEARING E3 RIGHT
• Type of Device: 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: 13424838
• MDR Text Key: 284891796
• Report Number: 0001825034-2022-00227
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279515646
• UDI-Public: (01)05019279515646(17)240603(10)885010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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: 154370
• Device Lot Number: 885010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White