MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 7X26MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210062

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 11/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-210034 explor 16x22mm implant head unknown.11-210025 explor 16x20mm implant head 522450.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04271.

Event Description

It was reported that x-rays determined that the connection between the radial head and stem was loose and there was wear reported on the cone/screw.There has not been any further reported patient intervention or revision at this time.

Event Description

It was reported that the patient underwent and initial elbow arthoplasty.Subsequently was found having pain and x-ray review on the follow showed loosening of the connection between head and stem.Finally, was revised due to pain and loosening, ten months post primary implantation.No additional information is available from the event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned products found light damages such as wear marks, scratches, and nicks.Inspection of the stem threads found the opening to be damaged.Inspection of the screw threads found burrs on each of the threads.Review of the available medical records/radiographs identified the following: 4 views of the right elbow demonstrate a radial head arthroplasty which demonstrates radiolucency surrounding the radial stem, consistent with loosening.Possible disconnect of the radial head and radial stem connection.Bony fragmentation along the common extensor tendon suggests prior trauma.Minimal calcification is also seen along the common extensor tendon attachment to the humerus.No joint effusion.No definite acute fracture.Review of the device history record (dhr) found additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.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: EXPLOR 7X26MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10950240
• MDR Text Key: 219897748
• Report Number: 0001825034-2020-04272
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-210062
• Device Lot Number: 765440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR