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

Model Number N/A

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 11-210032, explor 12x22mm implant head, 294650.Customer has been indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.

Event Description

It was reported that a patient underwent an initial elbow procedure.Subsequently, the patient was revised due to loosening and pain.The surgeon noticed radiographically that the screw had completely backed out of the radial head and was free floating in the patient's joint.The surgeon removed the modular head and loose screw from the joint.The radial stem was well-fixed and remained implanted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

(b)(4).Reported event was confirmed through x-rays received.The x-ray review indicated the presence of a loosened and free floating screw present in the dorsal aspect of the proximal radioulnar joint.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6980965
• MDR Text Key: 90354496
• Report Number: 0001825034-2017-09630
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: PK051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-210099
• Device Lot Number: 217080
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• 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
• Patient Age: 38 YR
• Patient Weight: 137