MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-MOM-HEADS-UNK; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).A cross-sectional study of 300 metal on metal total hip arthroplasties with metal artefact reducing sequence magnetic resonance imaging scanning and longitudinal follow-up at an average of 2 years: high progression rates in patients with established disease under observation (b)(6).1trauma and orthopaedics, (b)(6) hospital, 2radiology, (b)(6) hospital.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2020-02884.

Event Description

It was reported in a journal article that 38 hips were revised and presented with a more aggressive disease pattern.Attempts have been made and additional information on the reported event is unavailable at this time.

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 review was unable to be performed as the part and lot number of the device involved in the event is unknown.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: HIP-MOM-HEADS-UNK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10309197
• MDR Text Key: 199987084
• Report Number: 0001825034-2020-02883
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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: 07/12/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: HIP-MOM-CUPS-UNK
• Patient Outcome(s): Other