MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-RT 60; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#: 184766; series a pat std 34 3 peg; lot#: 927260; item#: 189042; vngd ant stblzd brg 12x67; lot#: 974520; item#: 141314; biomet finned pri stem 40mm; lot#: 144020; item#: 141212; biomet ilok pri tib tray 67mm; lot#: 711550.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.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: 0001825034 - 2020 - 04095, 0001825034 - 2020 - 04096.

Event Description

The patient underwent a mua approximately 1.5 months after an initial right unilateral tka.

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.

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.Reported event was confirmed by review of medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: one month visit ¿ (b)(6) 2020: generalized/unspecified knee pain, normal laxity and alignment.Rom 10-80, outpatient pt ¿ 10-12 visits.(b)(6) 2020 - ambulating with a cane, compliant with weightbearing status, good pain relief with medications, having some ankle pain due to swelling, negative for dvt, wound healing well, wean from narcotics, leg rewrapped for swelling, return in 4 weeks.(b)(6) 2020- pain with activities such as bending but otherwise good pain control, not satisfied with current level of activity, using walker for assistance, significant pain and swelling over the knee with tenderness to touch, incision well-healed, rom -5-75°, patient is intolerant to nsaids, provided with oral steroid dose pack, prescribed pt, pain and swelling are not called out as this is an expected finding in this postoperative period.In addition, the patient has rheumatoid arthritis, which is an autoimmune disease in which this would also be an expected finding.(b)(6) 2020 - right knee arthrofibrosis, mua performed without complication achieving rom 0-120° (b)(6) 2020 - pain with activity improving and controlled, using cane and walker for assistive device, feels she is losing progress on her rom demonstrating -15-100° in pt, rom -15-95°, flexion contracture is present, x-ray: there is a linear radiopaque object in the trochlea seen on the sunrise and lateral xr.This may indicate loose body or cement within the knee, developed a petechial rash on her rle that has improved with topical cortisone (not captured as complaint as a rash can have a variety of causes.Surgeon notes incision is well healed.Event started outside of the period it could be attributed to device/procedure)., surgeon stated: we do not have a good explanation for her continued pain and now loss of rom.She seems to have had a hyper-inflammatory response to surgery and formed abundant scar tissue.Her underlying ra and lupus may be playing a role.Aspiration performed to rule out infection, fluid was red tinged synovial fluid without gross purulence, with normal inflammatory labs, i think infection is very unlikely.Plan for possible arthroscopic lysis of adhesions vs.Revision.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.

• Brand Name: VANGUARD CR ILOK FEM-RT 60
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10829243
• MDR Text Key: 215932912
• Report Number: 0001825034-2020-04094
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304270374
• UDI-Public: (01)00880304270374
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183004
• Device Lot Number: J6793821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 64