MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PS ARTICULAR SURFACE 11MM; PROSTHESIS, KNEE

Catalog Number 42512400911

Device Problems Unstable (1667); Noise, Audible (3273); Migration (4003)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona cemented ps femoral component size 7, catalog # 42500606201, lot # 63581105; persona cemented tibial component, catalog # 42532007901, lot # 63609763; persona all poly patella 32mm, catalog # 42540200032, lot # 63550406.Our investigation is ongoing.A follow-up/final report will be submitted when additional information becomes available.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2018-00158, 3007963827-2018-00160, 0002648920-2018-00697.Location of device is unknown.

Event Description

It was reported that the patient underwent a left knee procedure.Subsequently, the patient complained of instability, snapping, popping, pain and swelling.The patient was revised due to pain and infection.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Reported event was confirmed by review of x-rays and operative notes.Review of the operative notes dated left incision and drainage with poly liner exchange due to pain and decreased range of motion.Surgeon notes implant loosening, possible infection upon x-ray review.Cloudy synovial fluid aspirated from knee joint.The surgeon notes that the left knee appears to be infected.The review of x-rays from identified no loosening or fracture.X-rays identified a healed fracture.The healed fracture is on the mid diaphysis of the left femur and is not on the knee area.Dhr was reviewed and no discrepancies were found.A definite root cause cannot be determined.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 PS ARTICULAR SURFACE 11MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7891636
• MDR Text Key: 120821010
• Report Number: 0001822565-2018-05093
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 42512400911
• Device Lot Number: 63631532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• 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: 61 YR
• Patient Weight: 99