MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Osteolysis (2377); Ambulation Difficulties (2544); Tissue Breakdown (2681); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 10/11/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown - unknown femoral component - unknown.Unknown - unknown tibial component - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00376, 0001822565-2023-00377.

Event Description

It was reported that a patient underwent an initial knee arthroplasty.Subsequently, the patient has been complaining of swelling, instability, and pain.They also note the knee is hot to the touch and the leg below the kneecap is bellying out.The patient has seen multiple physicians and has had x-rays taken.With physical testing, they doctors have noticed there is loosening.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a1; a4; b4; b5; b6; b7; d2; e1; g1; g3; g6; h1; h2; h3; h6 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total knee arthroplasty due to a work-related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complained of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement, cortical defect/osteolysis noted in the medial femoral condyle, potential subsidence of the tibial stem.The complaint was confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 00596401651 - femoral component option size f left compatible with lps-flex prolong - 63404818.00598005701 - stemmed tibial component precoat size 7 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 63283972.00111314001 - palacos rg 1x40 single - 84344539.00111314001 - palacos rg 1x40 single - 84344539.00597206538 - all poly patella standard cemented size 38 mm diameter 9.5 mm thickness - 62939856.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00356; 0002648920-2023-00316; 0001822565-2023-03753; 0001822565-2023-03756.

Event Description

It was reported that the patient underwent an initial left total knee arthroplasty due to a work related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complaint of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Subsequently, the patient was revised approximately 7 years post-op due to aseptic loosening.During the revision, the surgeon noted osteolysis to the tibia and femur, a large defect secondary to chronic loosening, and fibrous membrane formation.The tibia, femur, and articulating surface were exchanged with competitor products without complications.The patella remained implanted.Attempts have been made and all available information has been provided.

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.The device history record was reviewed.And no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed, by a health care professional.Review of the available records, identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement.Cortical defect/osteolysis noted, in the medial femoral condyle, potential subsidence of the tibial stem, osteolysis of the femoral condyle, large central cavitary defect in the tibial metaphysis, fibrous membrane formation.Root cause remains unchanged.If any further information is found, which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52
• 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: 16381317
• MDR Text Key: 309604326
• Report Number: 0001822565-2023-00378
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2024

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00596205110
• Device Lot Number: 62994139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/14/2023; 04/13/2023; 12/12/2023; 05/16/2024
• Supplement Dates FDA Received: 04/04/2023; 04/13/2023; 12/28/2023; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 101 KG