MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKOWN CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 11/19/2018

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.

Event Description

It was reported the patient underwent a left hip revision approximately 2 years post implantation due to elevated metal ion levels, metallosis, pain and a dislocation.No additional information.

Manufacturer Narrative

Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues metallosis caused by the competitor head and/or zimmer implants, lab results showing increased ion levels, pain and dislocations, instability as noted.Black fluid staining, head deformed and worn, no corrosion shell and stem well fixed.Device history record (dhr) was reviewed and no discrepancies were found.Cause was not established.Upon reassessment of the reported event, the shell was determined to be not reportable.The initial report was forwarded in error and should be voided.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

Upon reassessment of the reported event, the shell was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: UNKOWN CUP
• 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: 12174973
• MDR Text Key: 261888384
• Report Number: 0001822565-2021-01917
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MICROPORT FEMORAL HEAD CAT# 26012804, LOT 1667751; POLYETHYLENELINER CAT#7110-48-28 LOT# 62895935
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 87 KG