MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PS VE ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: persona all poly patella catalog # 42540000032 lot # 62445364.Persona ps narrow femoral catalog # 42500006401 lot # 62369093.Persona stemmed 5-degree tibia catalog # 42532007101 lot # 62424063.Persona ps ve articular surface catalog # 42512400710 lot # 62409274.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.Multiple mdr reports were filled for this event: 0002648920-2020-00286.3007963827-2020-00147.0002648920-2020-00288.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing pain and difficulty in range of motion.The patient underwent a manipulation under anesthesia with cortisone injection due to arthrofibrosis.

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 provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records review indicates that on (b)(6) 2014 patient experience pain and difficulty progressing with rom for 7 weeks follow tka, diagnosed with stiffness/arthrofibrosis.Mua with cortisone injection was performed there are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

• Brand Name: PERSONA PS VE ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10112332
• MDR Text Key: 195246646
• Report Number: 0001822565-2020-01954
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 42512400710
• Device Lot Number: 62409274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68