MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM H; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Item #:unknown, unknown head lot #:unknown, item #:unknown, unknown stem lot #:unknown, item #:unknown, unknown cup lot #:unknown.Customer has indicated that the product will 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 has been reported that the liner would not sit down flush.No further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d4, d10, g4, h2, h3, h4, h6 reported event was confirmed by visual examination of device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One g7 freedom const e1 lnr 36mm h was returned and evaluated.Upon visual inspection there is damage to the locking feature.There is also scratching on the outer radius.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

No further event information available at the time of this report.

• Brand Name: G7 FREEDOM CONST E1 LNR 36MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9695773
• MDR Text Key: 203141629
• Report Number: 0001825034-2020-00648
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000986
• Device Lot Number: 6483866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1