MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK M2A TAPER LINER PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dyspnea (1816); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Dizziness (2194); Neck Pain (2433); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530)

Event Date 03/04/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 - 2021 - 03510.

Event Description

It was reported the patient underwent a right hip tha. The patient underwent a revision due to dizziness, neck and back pain, toothache, shortness of breath, headache, groin pain, nausea, rashes, thumb pain, metallosis and bone loss. Attempts have been made and no further information has been provided.

• Brand Name: UNK M2A TAPER LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13112070
• MDR Text Key: 282953840
• Report Number: 0001825034-2021-03511
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNK M2A TAPER LINER
• Device Lot Number: 534210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1

Treatment

CAT#UNK M2A HEAD LOT#224730