MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PS+ TIB BRG 10X59MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Post Operative Wound Infection (2446); Tissue Breakdown (2681); Blister (4537); Swelling/ Edema (4577)

Event Date 01/02/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 183124 vanguard ps open intl fem-lt 60 lot# unk mdr: 0001825034-2024-00732.141230 vanguard biomet cc cruciate tray 59mm lot# unk mdr: 0001825034-2024-00733.

Event Description

It was reported via phone from patient that her post operative wound took several months to heal due to infection.The patient underwent a second surgery to clear the infection.Currently experiencing knee stiffness, pain.Site of surgery is puffy, red and spreading with itching.Had patch test.Only reaction was manganese chloride.1% max.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h6, h10.The device history records were not reviewed as the lot number associated with the reported event is unknown and the reported event was determined to be unrelated to the implanted device.Superficial infections are considered procedure-related complications as no device has been reported as revised.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.During the investigation process a review of the sterile certifications were not reviewed, as no product lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As the reported event was considered procedure-related, the root cause was determined to be unrelated to the implanted zimmer biomet device.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.

Event Description

It was reported the patient underwent a superficial i&d 3 months post procedure due to an allergic reaction to the aquacel dressing applied after initial procedure.The patient had a blister that turned into eschar.During the i&d suture was noted in the medial pocket which was debrided and sent to pathology along with the eschar tissue without complications.Wound vac and knee brace applied with instructions of keeping leg straight for 2 weeks.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the results of the previous investigation remain unchanged.The device history records were not reviewed as the lot number associated with the reported event is unknown and the reported event was determined to be unrelated to the implanted device.Superficial infections are considered procedure-related complications as no device has been reported as revised.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.During the investigation process a review of the sterile.Certifications were not reviewed, as no product lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu guidelines.As the reported event was considered procedure-related, the root cause was determined to be unrelated to the implanted zimmer biomet device.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.

• Brand Name: VANGUARD PS+ TIB BRG 10X59MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18908498
• MDR Text Key: 337730165
• Report Number: 0001825034-2024-00734
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 183700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 58 KG