MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 40 MM DIAMETER; PROSTHESIS, SHOULDER

Catalog Number 00434904011

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Pain (1994); Joint Dislocation (2374)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent initial shoulder arthroplasty.Subsequently, the patient was revised due to dislocation of the head, pain, and hematoma nine days post primary implantation.The surgeon removed the head and implanted a new one of the same size.No other patient consequences are known at this time.

Event Description

Upon receipt of additional information, it was determined that the baseplate disassociated from the glenosphere.No additional patient consequences were reported.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified scratches and dings on the glenosphere surface.Review of the available radiographs identified the following: possible metal on metal contact of hardware at glenohumeral joint; appearance of reverse shoulder arthroplasty.Device history record (dhr) was reviewed and no discrepancies were found.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: GLENOSPHERE 40 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8885642
• MDR Text Key: 154040728
• Report Number: 0001822565-2019-03391
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434904011
• Device Lot Number: 64288880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK BASEPLATE
• Patient Outcome(s): Hospitalization; Required Intervention