MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR IMPLANT LOCKING SCREW; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported patient is experiencing range of motion issues in extension since the locking screw was revised.No further information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr's are associated with this reporting: 0001822565 - 2020 - 00199, 0001822565 - 2020 - 00200.Updated: d11, h2, h3, h6, h10.Reported event was unable to be confirmed due to the limited information received from the customer.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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: EXPLOR IMPLANT LOCKING SCREW
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9027210
• MDR Text Key: 160430991
• Report Number: 0001825034-2019-04057
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210493
• UDI-Public: 00880304210493
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 11-210099
• Device Lot Number: 690690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN PART/LOT, UNKNOWN HEAD; UNKNOWN PART/LOT, UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 94