MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID BASEPLATE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 118001, versa-dial/comp ti std taper, 557180, 115330, comp rvrs shdr glen bsplt +ha, 094150.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034 - 2018 - 02026.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Subsequently, the patient was revised due to disassociation.It was stated that "no fall or unusual event" had occured.The x-ray revealed the disassociation of the adapter/baseplate interface.During the revision, the glenosphere and adapter were solidly engaged and removed.The construct had disassociated from the baseplate.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

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

It was reported that the patient underwent revision surgery for the shoulder approximately 2 months post initial surgery due to disassociation.The onset of the event was two days prior when the patient raised his arm and disassociated the glenosphere from the base plate.During the revision, the glenosphere and adapter were solidly engaged and removed.The construct had disassociated from the baseplate.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays and photos provided.X-rays were received and reviewed.Per the review, "disassociation of the adapter and base plate interface is present on the image dated (b)(6) 2018.No obvious signs of trauma.Patient is osteopenic.No other contributing factors are seen." inspection of the photos provided showed scratches/wear on the taper and taper face.These likely occurred from the taper disengaging and floating in the joint space.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: GLENOID BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7353459
• MDR Text Key: 102939176
• Report Number: 0001825034-2018-02027
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• 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: 05/08/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115330
• Device Lot Number: 094150
• Other Device ID Number: (01) 0 0880304 47534 2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 05/08/2018
• Supplement Dates FDA Received: 05/02/2018; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR