MAUDE Adverse Event Report: ZIMMER BIOMET DRILL BIT; BIT, DRILL

Model Number 3.2MMX30MM RNGLC+ ACET DRL BIT

Device Problem Nonstandard Device (1420)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191)

Event Date 09/11/2020

Event Type  Injury  

Event Description

Patient had a right total hip arthroplasty on (b)(6) 2020.She presented to the hospital with fever, chills and severe right hip pain in (b)(6) 2021.Aspiration revealed infection.Patient required repeat surgery.She also had another admission related to this problem.A drill bit used in the original total hip arthroplasty from zimmer was in the recall lot for possible sterility issues.This is related to zimmer recall of multiple products for possible violation of sterility.Field action reference: zfa 2020-00316.Patient had hip aspiration which showed increased cell counts and eventually positive culture fda safety report id # (b)(4).

• Brand Name: DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 11946681
• MDR Text Key: 254913235
• Report Number: MW5101739
• Device Sequence Number: 1
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.2MMX30MM RNGLC+ ACET DRL BIT
• Device Catalogue Number: 31-323230
• Device Lot Number: 508000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 92