MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 10/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Unique identifier (udi) #: (b)(4).Concomitant medical products: 00-4349-038-11, base plate uncemented, lot 64066599.20-8075-001-001, trabecular metal, reverse glenoid left, lot 64184973.00-4349-016-13, humeral stem 16 mm stem diameter 130 mm stem length, lot 63897097.00-4349-036-03, poly liner plus 3 mm offset 36 mm diameter, lot 63842514.01.04223.036, invers/revers scr syst 4.5-36, lot 2936881.01.04223.033, invers/revers scr syst 4.5-33, lot 2940193.Event occurred in (b)(6).

Event Description

It was reported that approximately 3 days post implantation, the patient was revised due to malpositioning of the glenosphere, which was not seated on the baseplate.Attempts have been made and no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: reported event was confirmed by review of radiographs.X-ray review showed displacement of the glenosphere from the baseplate of the l shoulder arthroplasty.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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.

Event Description

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

• Brand Name: GLENOSPHERE 36 MM DIAMETER
• 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: 8037323
• MDR Text Key: 126085025
• Report Number: 0001822565-2018-06033
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 64017088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113