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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: unknown, glenoid, lot # unknown, catalog #: unknown, humeral head, lot # unknown.Reported event was considered confirmed from the x-rays provided which showed on the axillary view dislocation of the shoulder arthroplasty.No fracture is identified.Also, osteolysis along the glenoid implant and along the proximal humeral implant.Bone quality is osteopenic.There is advanced arthrosis of the acromioclavicular joint and prominent subacromial spurring.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 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02918, and 0001825034 - 2020 - 02881.Location unknown.

Event Description

It was reported that a patient underwent a right shoulder arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.X-rays reviewed show joint dislocation.Attempts have been made and there is no additional information available at this time.

• Brand Name: UNKNOWN HUMERAL STEM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11064833
• MDR Text Key: 223396868
• Report Number: 0001825034-2020-04347
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2020

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: 12/07/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention