MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971); Sepsis (2067); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: 150480 - oss axle - 171230; 150477 - oss poly femoral bushings - 054370; 150354 - oss 7cm segmental femoral rt - 587060; 150410 - oss tibial poly bearing 12mm - 413680; 150478 - oss poly lock pin - 669540; 150476 - oss poly tibial bushing - 416420. The customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00623, 0001825034-2021-00624, 0001825034-2021-00626, 0001825034-2021-00627, 0001825034-2021-00628, 0001825034-2021-00629.

Event Description

It was reported that the patient underwent a right knee revision. Subsequently, the patient was revised approximately one month later due to unknown reasons. Attempts have been made and no further information has been provided.

• Brand Name: OSS REINFORCED YOKE
• 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: 11423297
• MDR Text Key: 235007002
• Report Number: 0001825034-2021-00625
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 264310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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 Treatment Data

Date Received: 03/05/2021 Patient Sequence Number: 1