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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unknown-unk, mom head-unknown; unknown-unk, mom cup-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02026, 0001825034 - 2020 - 02030.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient is being considered for a revision on an unknown day for an unknown reason.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient underwent a revision surgery for a possible implant failure.There was no delay or complication during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left hip arthroplasty with disassociation at the junction of femoral head and stem.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.Discarded by hospital.

• Brand Name: UNKNOWN BIMETRIC STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10065832
• MDR Text Key: 193629802
• Report Number: 0001825034-2020-02031
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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
• Date Manufacturer Received: 05/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention