MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUTED STEM EXTENSION STRAIGHT PRECOAT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient previously underwent surgeries for femoral fracture and enterobacter infection.A definitive root cause cannot be determined.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-0923.

Event Description

It was reported that patient had a total knee arthroplasty and was revised due to disassociation, severe pain, swelling, and drainage associated with a previous infection.Attempts have been made and no further information has been provided.

• Brand Name: FLUTED STEM EXTENSION STRAIGHT PRECOAT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11156970
• MDR Text Key: 226648074
• Report Number: 0001822565-2021-00138
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024197732
• UDI-Public: (01)00889024197732(10)290430(10)64287779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585205012
• Device Lot Number: 64287779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 136