MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M/L TAPER STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Cyst(s) (1800); Necrosis (1971); Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown kinectiv neck, unknown head, unknown liner, unknown cup.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: 0001822565 - 2021 - 00421, 0001822565 - 2021 - 00422.

Event Description

It was reported the patient underwent a right hip revision approximately 11 years post implantation due to unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6b - based on additional information, the product was confirmed to not be removed during the revision procedure.Therefore, this field needs to be blank.D10: unknown longevity acetabular liner, unknown kinectiv neck, unknown cup, femoral head cat# 00-8018-036-02 lot# 60774028.

Event Description

It was further reported through patient's medical records that the patient underwent a right hip revision approximately 11 years post implantation due to elevated metal ion levels, synovitis, pain, pseudotumor, metallosis, bone erosion, instability, cyst, necrosis, scar tissue, in-vivo corrosion, and osteolysis.

Manufacturer Narrative

Upon reassessment of the reported event, the stem was determined to be not reportable as there was no allegations against the product.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the stem was determined to be not reportable as there was no allegations against the product.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN M/L TAPER STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11335563
• MDR Text Key: 232322808
• Report Number: 0001822565-2021-00418
• Device Sequence Number: 1
• Product Code: JDI
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/10/2021; 05/12/2021
• Supplement Dates FDA Received: 02/23/2021; 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H0 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention