MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown m2a cup, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -11395.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted in patient.

Event Description

It was reported that the patient underwent an initial hip surgery on an unknown date.Subsequently, the patient is suffering from elevated metal ions and discomfort.No revision reported.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.Device not returned for evaluation.

Event Description

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

• Brand Name: UNK M2A HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8182823
• MDR Text Key: 130972314
• Report Number: 0001825034-2018-11394
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: UNK M2A HEAD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other