MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 42500006001; femur cemented posterior stabilized (ps) narrow left size 6 lot#: 63690665; item#: 42532006701; tibia cemented 5 degree stemmed left size d lot#: 63727290; item#: 42540000029; all poly patella cemented 29 mm diameter lot#: 63785212.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left tka 3.5 years ago.Subsequently, the patient was revised on 1.5 months ago due to instability, pain, difficulties with activities of daily living, and a large effusion; onset of symptoms was 6mo prior to revision with no documented cause.Patellar, tibial, and femoral components well fixed and not removed.
Event or Problem Description
No further event information available at the time of this report.
Additional 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 dhr was reviewed and no discrepancies relevant 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: office visit: pain 6 out of 10, swelling, pain with activity, instability, limps; pain with bending, swelling causes instability; physical therapy for bilateral knees and brace has not helped; left knee exam, large effusion, hyperextending 5 degrees with flexion to 120, anterior pain, well fixed and well aligned; instability medial aspect at 30 degrees; op notes: labs negative for infection, bone scan negative for loosening, 1+ instability noted in med flexion, rom -2 hyperextension to 110, large effusion aspirated, healthy synovial fluid, patella, tibial, femoral components well fixed not removed, 14 mm cps poly chosen with loss of 4 degree extension but excellent stability in all rom.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no radiolucency, no evidence of loosening, no hardware failure or malfunction, small to moderate joint effusion, overall fit and alignment is appropriate, normal bone quality, no contributing factors.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: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT 11 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11434600
• Report Number: 0001822565-2021-00612
• Device Sequence Number: 19737566
• Product Code: MBH
• UDI-Device Identifier: 00889024237094
• UDI-Public: (01)00889024237094(17)220831(10)63753072
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400511
• Device Lot Number: 63753072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68