MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SHOULDER PROSTHESIS; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent initial left elbow arthroplasty.Subsequently; the patient is experiencing squeaking in the prosthesis approximately 10 years post implantation.X-rays taken show a bolt in the implant has loosened.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of x-rays received.Radiographs were reviewed and identified a left total elbow arthroplasty with disassembly of the hinge joint mechanism.Screw from the radial aspect is loose in the radial soft tissues.Radiolucency along the lateral aspect of the humeral component consistent with loosening.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN SHOULDER PROSTHESIS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10747024
• MDR Text Key: 213404656
• Report Number: 0001825034-2020-03925
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other