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

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); Weight Changes (2607)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: persona ps femoral component, catalog # 42500606402, lot # 63392876; persona stemmed tibial component, catalog # 42532007502, lot # 63361112; persona all poly patella, catalog # 42540200035, lot # 63378501.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2019-00239, 0002648920-2019-00621, 0002648920-2019-00622, remains implanted.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently the patient was experiencing pain and instability six months post operative.No revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Per the persona knee system package insert (87-6204-022-23, rev.A), pain and instability are known potential adverse effects of this procedure.A definitive 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
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8907667
• MDR Text Key: 154782643
• Report Number: 0001822565-2019-03534
• 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: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522400712
• Device Lot Number: 63395701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 135