• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. OSS REINFORCED YOKE PROSTHESIS, KNEE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOSS REINFORCED YOKE
Type of DevicePROSTHESIS, 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 Key11604413
MDR Text Key247515474
Report Number0001825034-2021-00963
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052685
Number of Events Reported1
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 Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number150493
Device Lot Number933270
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 Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/01/2021 Patient Sequence Number: 1
-
-