MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A MOD HEAD STD NK; 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  

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.

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: 0001825034-2021-03511.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d1, d2, d4, g3, g4, h2.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

• Brand Name: 32MM M2A MOD HEAD STD NK
• 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: 13112079
• MDR Text Key: 282940368
• Report Number: 0001825034-2021-03510
• Device Sequence Number: 1
• Product Code: JDL
• 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

1 Device was Involved in the Event

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: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 11-163669
• Device Lot Number: 224730
• 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: 10/01/2002
• 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 Sequence Number: 1
• Treatment: CAT#UNK M2A TAPER LINER LOT#534210
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female