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

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: therapy date: unknown, unk m2a cup, unk m2a taper.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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: 0001825034-2020-01580.0001825034-2020-01583.

Event Description

It was reported that the patient underwent an initial left hip arthroplasty on an unknown date.The patient states he has been diagnosed with elevated crco numbers that are 5 times higher than what they should be.It was also noted that he is scheduled for an mri and possible revision.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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 is 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

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: 9940736
• MDR Text Key: 190201766
• Report Number: 0001825034-2020-01579
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 109