MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM 80X10MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Unspecified Infection (1930)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item 189122 lot 919030.Item 141216 lot 323010.Item 184788 lot 345980.Item unknown lot unknown vanguard femoral report source: foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will not allow release of the product.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: 0001825034-2020-04251, 0001825034-2020-04252, 0001825034-2020-04254, 0001825034-2020-04255.

Event Description

It was reported patient underwent a knee revision procedure.Subsequently, patient underwent a revision three months later due to infection as per cultures taken during the revision.Implants removed, washed with pulse lavage and a first stage implant was implanted.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were 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, for products with known part/lot information.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: BIOMET FINNED PRI STEM 80X10MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10934928
• MDR Text Key: 219167481
• Report Number: 0001825034-2020-04253
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• 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: 141316
• Device Lot Number: 065580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention