MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown, unk cup, unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.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 - 02494.

Event Description

It was reported the patient underwent a revision surgery approximately 1-month post implantation due to unknown reasons.During the procedure the liner and cup was revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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

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

Manufacturer Narrative

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

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10191985
• MDR Text Key: 197564661
• Report Number: 0001825034-2020-02498
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup
• Report Date: 05/20/2021

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?: No
• 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: 05/29/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 05/05/2021
• Supplement Dates FDA Received: 08/18/2020; 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention