MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-UNKNOWN-PATELLA-; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); No Information (3190)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs: kne-unknown-tibial- mdr: 0001825034-2021-00268.Kne-unknown-femoral- mdr: 0001825034-2021-00269.Kne-unknown-bearing- mdr: 0001825034-2021-00270.

Event Description

It was reported by the pmi group that a patient underwent a left knee arthroplasty.Subsequently, approximately 6 months post procedure the patient is being considered for a pmi product on an unknown day for an unknown reason.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Radiographs were provided and x-ray evaluation by third party healthcare professional confirms that the locking screw was displaced.Review of the available radiographs identified the following: knee alignment is maintained with no fracture; the poly locking screw is displaced and extends into the knee joint; bone quality is osteopenic.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

No further event information available at the time of this report.

• Brand Name: KNE-UNKNOWN-PATELLA-
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11243662
• MDR Text Key: 229166751
• Report Number: 0001825034-2021-00271
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/11/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KNE-UNKNOWN-PATELLA-
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/11/2021
• 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