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

Catalog Number 00434903611

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

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 - 00607, 0001822565 - 2020 - 00608.

Event Description

It has been reported patient underwent shoulder arthroplasty on an unknown date.Subsequently patient underwent revision due to dislocation due to a fall.The glenoid head disassociated from the baseplate.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.

Event Description

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

Manufacturer Narrative

Visual examination of the returned product identified heavy gouges and wear on liner.Dimensional analysis was performed on the glenosphere taper and was found to be confirming.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to patient trauma.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 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9727865
• MDR Text Key: 189463319
• Report Number: 0001822565-2020-00606
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

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 Catalogue Number: 00434903611
• Device Lot Number: 63960577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 07/10/2020
• Supplement Dates FDA Received: 03/04/2020; 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BASEPLATE, CAT#NI LOT#NI.; UNKNOWN POLY LINER, CAT#NI, LOT#NI.
• Patient Outcome(s): Hospitalization; Required Intervention