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.

Manufacturer Narrative

D10: 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 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 150493 - oss reinforced yoke - 933270 150425 - oss mod tib baseplate 83mm - 978210 150362 - oss cemented im stem 13mmx90mm - 178750 this follow-up report is being submitted to relay additional information.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, 0001825034-2021-00626-1, 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, 0001825034-2021-00963, 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.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.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: OSS REINFORCED YOKE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11423297
• MDR Text Key: 235007002
• Report Number: 0001825034-2021-00625
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)290228(10)264310
• Combination Product (y/n): N
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150493
• Device Lot Number: 264310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/20/2021; 06/09/2021
• Supplement Dates FDA Received: 04/01/2021; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention