MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD ARTHRO NL SM LK COLLAR BOLT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01118 and 0001825034-2020-01119.Concomitant medical devices: md arthro nl sm lk collar bolt catalog#: cp260603 lot#: ni, md arthro nl sm lk collar bolt catalog#: cp260603 lot#: ni, md arthro nl sm lk collar bolt catalog#: cp260603 lot#: ni, unknown diaphyseal connector catalog#: ni lot#: ni, unknown oss collar catalog#: ni lot#: ni, unknown oss compress catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a knee procedure on an unknown date ten years ago.Subsequently, the patient heard a pop and x-rays displayed two fractured screws.The patient was revised and the collar was replaced.No additional information is available.

Manufacturer Narrative

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

Event Description

Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.

• Brand Name: MD ARTHRO NL SM LK COLLAR BOLT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9828678
• MDR Text Key: 183374208
• Report Number: 0001825034-2020-01119
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K042409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP260603
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2020
• 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