MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR (PS) RIGHT 10 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient-reported to be happy with the progress from mua previously performed.X-ray reported stated on (b)(6) 2019 noted no complications seen with implants, prominent effusion and swelling apparent which is increased since the last exam.However, the patient fell while exercising, the cause of the fall is unknown.After the fall patient states the patella was dislocated and experienced swelling.Rom-5-115 was noted with no instability, the patient was instructed to wear a brace to aid soft tissue healing.Xray's report after the fall found no evidence of loosening, osteopenia, unchanged small metallic density, and calcification projecting over the medial thigh, patella baja.The patient has reported improvement of pain/swelling with neoprene brace, rom 0-90°, diagnosed with mcl sprain after fall.Severe fibrosis of the fat pad that was adhered to the notch anteriorly, medial and lateral aspects of the knee was debrided to remove severe fibrosis.There was a minimal scar in the suprapatellar pouch.Rom 0-120° was achieved at end of the procedure.The patient reports he was doing well until he was diagnosed with covid and stuck in bed for 3 weeks after which he reported increased pain and stiffness, rom now 0-90.The patient continues to experience pain, tightness, swelling at end of the day, now using a cane, rom 7-90°, the patient continues to be unsatisfied.Xray report states tka in functional position, minimal heterotopic calcification, few metallic densities in the medial soft tissue.The complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products and mdrs: 42500606802 femur cemented posterior stabilized (ps) std rt size 10 lot# 63917184 mdr: 3007963827-2021-00170.42532007502 tibia cemented 5 degree stemmed right size f lot# 63992332 mdr: 3007963827-2021-00171.42540200032 all-poly patella cemented 32 mm dia lot# 64014619 mdr: 0002648920-2021-00220.
Event or Problem Description
It was reported that patient underwent right total knee arthroplasty.Subsequently, the patient has been experiencing pain, limited rom, difficulty ambulating, and swelling.He underwent an arthroscopy procedure 10 months post-procedure to remove fluid & scar tissue.The patient continued to do well until he fell due while walking resulting in patellar dislocation which he reduced himself and was braced for an mcl sprain.25 months after initial procedure, he underwent a second arthroscopic lysis of adhesions with manipulation but experienced difficulties with therapy and exercises postop due to covid recovery.The patient remains dissatisfied with his knee due to ongoing pain, swelling, and decreased rom.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR (PS) RIGHT 10 MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12307370
• Report Number: 0001822565-2021-02247
• Device Sequence Number: 11752896
• Product Code: JWH
• UDI-Device Identifier: 00889024243835
• UDI-Public: (01)00889024243835(17)230228(1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522400810
• Device Lot Number: 63930941
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/11/2021
• 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: 93