MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN OSS LOCKING COLLAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01119.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.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of x-rays.An x-ray was provided and reviewed by a health care professional.Review found abnormal anterior angulation of the device consistent with the reported mid-shaft screw fractures.Bone quality is osteopenic.There is no evidence of loosening, wear or abnormal radiolucency.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: UNKNOWN OSS LOCKING COLLAR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9828679
• MDR Text Key: 193049608
• Report Number: 0001825034-2020-01118
• 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

• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/17/2020
• 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