MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE 14MM HEIGHT SIZE D ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: all poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 64620652 right size d cemented option femoral component catalog#: 00588001402 lot#: 11024333 prc agmt block post sz d 5mm catalog#: 00599003401 lot#: 64394304 prc agmt block dist sz d 10mm catalog#: 00599003420 lot#: 64334530 prc agmt block dist sz d 10mm catalog#: 00599003420 lot#: 62932424 long 12mm diameter 155mm length offset stem extension combined length 200mm catalog#: 00598802112 lot#: 64099283 size 4 precoat cemented tibial component catalog#: 00588000400 lot#: 64639363 tibial full block augment precoat size 4 10 mm thickness catalog#: 00588000410 lot#: 63464613 trabecular metal tibial cone, medium 36x31mm catalog#: 00545001336 lot#: 63801886 10mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801010 lot#: 64748762 palacos r + g (1x40) catalog#: 66022663 lot#: 90614738 copal g+v cement catalog#: 66038973 lot#: 93844844 g2 foreign source: australia it was reported that approximately two years after a 2-stage revision total knee, a patient returned for a third revision due to synovitis and arthrofibrosis.The synovial membrane (synovium) encloses each joint and secretes fluid to allow joints to move freely.When the synovium is irritated by debris or pathogens, it over-secretes fluid causing local pain/tenderness, inflammation, swelling, and warmth, often resulting in mobility difficulties.Synovitis is treated with steroid injections to reduce the pain and inflammation or by arthroscopic or open synovectomy.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.

Event Description

It was reported that patient underwent a right knee revision arthroplasty.Subsequently, the patient was revised approximately two years later due to synovitis and arthrofibrosis.A total synovectomy with debridement, a second quadricepsplasty, and a poly exchange was performed.The retained tibial and femoral components were well-fixed with no signs of loosening.

• Brand Name: ROTATING HINGE KNEE 14MM HEIGHT SIZE D ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19047072
• MDR Text Key: 339431038
• Report Number: 0001822565-2024-01160
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024199316
• UDI-Public: (01)00889024199316(17)211031(10)63479671
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588004014
• Device Lot Number: 63479671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2016
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 70 KG