MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 14X24 MM IMPLANT HEAD; PROSTHESIS ELBOW

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Osteolysis (2377)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: unknown, 30mm stem, lot # unknown.Report source: (b)(6).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01642.Unknown if the product will be returned.

Event Description

It was reported that initial right total elbow arthroplasty was performed approximately 3 years ago.Subsequently, the patient was revised about 3 months ago due to pain and swelling.During the revision, it was noted that the screw had backed out causing disassociation of the radial head and stem.What appeared to be metallosis was present throughout.All components were removed, and antibiotic beads were placed.The patient was treated for infection.No additional information available at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: d4 (item).D11: medical product: catalog#: 11-210064, explor 9x30mm impl stem w/scr, lot#: unknown.Visual examination of the provided pictures identified the head, locking screw, and stem in a bag.The product appears to be cleaned and free of biomaterial.No further conclusions can be made regarding the condition of the product.Reported event was considered confirmed by the medical records that stated during the revision it was stated the locking screw had become disengaged and the soft tissue contained metallosis type coloring.From nine specimens sent for infection testing, one came back mildly positive.X-rays showed the radial head withdrawn from the radius partially and metallic fragment noted along the radial head inferiority.There were no fractures.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 14X24 MM IMPLANT HEAD
• Type of Device: PROSTHESIS ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9980798
• MDR Text Key: 188331535
• Report Number: 0001825034-2020-01640
• Device Sequence Number: 1
• Product Code: KWI
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 11-210043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2020
• 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
• Patient Weight: 73