MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 3 9 MM HEIGHT; PROSTHESIS, KNEE

Model Number 5842-23-09

Device Problem Unstable (1667)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: femoral component high flex precoat for cemented use only right medial/left lateral: catalog#00584201502, lot#63199765; tibial component precoat right medial/left lateral size 3: catalog#00584200302, lot#11017646.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2023-00022.The product will not be returned to zimmer biomet for evaluation, as the product location is unknown.The investigation is in progress.Upon completion of the investigation, a follow up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right partial knee arthroplasty.Approximately six months post implantation, the patient felt their implanted knee give way and fell down a set of stairs.The fall resulted in a fractured humerus bone in the shoulder which required surgical intervention to resolve.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  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.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified possible loosening or malposition of the right medial uni knee compartment.Complaint not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: ARTICULAR SURFACE SIZE 3 9 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; .; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16091380
• MDR Text Key: 306586033
• Report Number: 0001822565-2023-00023
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024193970
• UDI-Public: (01)00889024193970(17)230731(10)63118426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 5842-23-09
• Device Catalogue Number: 00584202309
• Device Lot Number: 63118426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 108 KG