MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL HEAD 24 MM HEAD HEIGHT 46 MM; PROSTHESIS, SHOULDER

Catalog Number 00430004624

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Subluxation (4525)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.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: 0001822565 - 2020 - 03424.

Event Description

It was reported that the patient had primary hemiarthroplasty in 2012.Subsequently, the patient underwent revision due to increased pain and stiffness.The humerus is mildly superiorly subluxed and there are signs of glenoid bone erosion.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of med records/radiographs reviewed by an hcp noting all of the internal and external rotation images demonstrate loss of joint space at the glenohumeral joint with bone and metal articulation seen between the central to inferior portion of the glenoid and the medial portion of the humeral head hardware.There is heterotopic bone seen inferior to the glenohumeral joint and likely some development of heterotopic bone along the superior margin of the humeral head component.No periprosthetic lucencies are confirmed, no bone fracture.Dhr was reviewed and no discrepancies were found.The root cause is 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: MODULAR HUMERAL HEAD 24 MM HEAD HEIGHT 46 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10634331
• MDR Text Key: 209974969
• Report Number: 0001822565-2020-03423
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 00430004624
• Device Lot Number: 61614039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 00434810913 HUMERAL STEM 48 DEGREES (B)(6).; 00434810913 HUMERAL STEM 48 DEGREES 61713313
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 73