MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 12 MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # (b)(4).Concomitant medical products: item 42500606802, lot 63487076.Item 42532007502, lot 63481089.Item 42557000114, lot 63548884.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00090, 3007963827-2020-00091, 0001822565-2020-01026.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.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 right total knee arthroplasty, subsequently; the patient was revised three years later due to pain and stiffness.During the revision, significant scar tissue was debrided.The tibial and femoral components were replaced without complication.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.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 related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: surgery notes indicating no intra-ops complication during initial and revision surgery.After the surgery patient had two trauma events that could enhance scar tissue buildup.On (b)(6) 2019, patient-reported not having good flexion along with pain and swelling.It should be noted that the patient had canceled the mua in due to health conditions.The patient was revised for arthrofibrosis, stiffness, difficulties with adls, rom -20-60°.A large amount of scar tissue was noted.X-ray review noted on the report found good prosthesis alignment, no evidence of loosening or subsidence.X-ray which was provided to the pms team was not reviewed ref (b)(4).This confirms the complaint.A definitive root cause cannot be determined.Per package insert persona the personalized knee system: pain, swelling, poor range of motion are known adverse effects of the system.If any further information is found which would change or alter any conclusions or information, a supplemental 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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING RIGHT 12 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9937748
• MDR Text Key: 194443020
• Report Number: 0001822565-2020-01025
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522600812
• Device Lot Number: 63350968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 06/11/2020
• 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 Age: 63 YR
• Patient Weight: 95