MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown cup; unknown head; unknown liner.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 -11462.

Event Description

It was reported that patient underwent a left hip revision due to osteolysis.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Device was not explanted.Review of radiographs provided could not confirm the reported osteolysis.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8183889
• MDR Text Key: 130980263
• Report Number: 0001825034-2018-11463
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• 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