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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971); Sepsis (2067); 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; 150493 - oss reinforced yoke - 264310; 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; 150410 - oss tibial poly bearing 12mm - 581070; 150477 - oss poly femoral bushings - 354010; 150476 - oss poly tibial bushing - 545940; 150480 - oss axle - 469410; 150478 - oss poly lock pin - 794330; 150425 - oss mod tib baseplate 83mm - 978210; 150362 - oss cemented im stem 13mmx90mm - 178750. 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: 0001825034-2021-00623-1, 0001825034-2021-00624-1, 0001825034-2021-00625-1, 0001825034-2021-00626-1, 0001825034-2021-00627-1, 0001825034-2021-00628-1, 0001825034-2021-00629-1, 0001825034-2021-00957, 0001825034-2021-00958, 0001825034-2021-00959, 0001825034-2021-00960, 0001825034-2021-00961, 0001825034-2021-00964, 0001825034-2021-00965.

Event Description

It was reported the patient underwent a right revision procedure approximately 3 months ago due to implant fracture. About one month later, the patient presented to the er with signs of infection and a revision of both femoral and tibial components from the right distal femur took place with an i & d and placement of wound vac due to infection. The following day the patient returned to the or for a planned debridement to minimize bacterial burden. The patient then returned to the or two days later for the 2nd stage of revision which included removal of antibiotic delivery device with reimplantation and revision of tibial component, right distal removal replacement with hinged component mechanism as well as excisional debridement of muscle, subcutaneous tissue. The patient required plastic surgeon for the complexity of the wound. Attempts have been made and additional information on the reported event is unavailable at this time.

• 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: 11604413
• MDR Text Key: 247515474
• Report Number: 0001825034-2021-00963
• 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
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 933270
• 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: 11/25/2020
• 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: 04/01/2021 Patient Sequence Number: 1