MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD (TM) KNEE DISTAL FEMORAL PEG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 09/06/2010

Event Type  Injury  

Manufacturer Narrative

(b)(54).Additional concomitant medical products: biomet interlok fixed i-beam tibial plate with locking bar catalog # 141222 lot # 875980; vanguard (tm) ps open box femoral interlok catalog # 183106 lot # 242920; biomet series a standard patella catalog # 184764 lot # 662110; vanguard (tm) dcm ps plus tibial bearing catalog # 183724 lot # 707590.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2018-05001, 0001825034-2018-05002, 0001825034-2018-05003, 0001825034-2013-05124.Remains implanted.

Event Description

It was reported that a patient enrolled in a clinical study underwent right total knee arthroplasty on an unknown date.Subsequently, the patient underwent irrigation and debridement on (b)(6) 2010 due to wound dehiscence and superficial infection.No products were removed or replaced.No further information has been provided to date.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited investigative inputs provided by the customer.Dhr was reviewed and no related manufacturing deviations or anomalies were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 (TM) KNEE DISTAL FEMORAL PEG
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7770110
• MDR Text Key: 116660633
• Report Number: 0001825034-2018-05000
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK033489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

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 Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 183099
• Device Lot Number: 285850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/24/2018
• 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
• Patient Age: 84 YR
• Patient Weight: 95