MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 15 MM POST LENGTH UNCEMENTED; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Tissue Damage (2104)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: 00430904400, base plate inserter, lot 61714735.Multiple mdr reports were filed for this event, associated reports: 0001822565 - 2018 - 06387.

Event Description

It was reported that during a primary shoulder procedure, the surgeon had prepared the glenoid to accept a 15 mm reverse baseplate.The baseplate was inserted and impacted into the glenoid.When the surgeon attempted to remove the inserter, it was wedged onto the baseplate, and would not release.The inserter was extracted with the baseplate still attached to it.The surgeon had to switch to a 25 mm peg reverse baseplate due to excess loss of tissue that occurred during the manipulation of the 15 mm reverse baseplate.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were update/corrected complaint sample was evaluated and the reported event was confirmed.As returned, the inserter seized with the baseplate and could not be disassembled.The inserter had a potential field age of 7 years.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: BASE PLATE 15 MM POST LENGTH UNCEMENTED
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8084887
• MDR Text Key: 127592820
• Report Number: 0001822565-2018-06386
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

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
• Device Catalogue Number: 00434901500
• Device Lot Number: 64015482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82