MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE UNCEMENTED; EXTREMITIES, IMPLANT

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial shoulder procedure.Subsequently, the patient was revised due to dissociation.No additional patient consequences were reported.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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

It was reported that patient underwent a revision procedure approximately seven years post-implantation due to loosening of the baseplate.Baseplate and poly were revised.No additional patient consequences were reported.

• Brand Name: BASE PLATE UNCEMENTED
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8674654
• MDR Text Key: 147189527
• Report Number: 0001822565-2019-02308
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00434903811
• Device Lot Number: 61764833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• 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 Weight: 120