MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip procedure, the poly would not seat in the cup.The surgeon noticed that the locking mechanism had started peeling.A new poly was opened and was able to be implanted successfully.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6.Complaint sample was returned and evaluated against the reported event.Visual examination of the returned product identified the locking feature of the device has been damaged and a piece has been shaved from the liner.Dhr was reviewed and no discrepancies were found.The root cause is 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: G7 NEUTRAL ARCOMXL LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11911738
• MDR Text Key: 255744733
• Report Number: 0001825034-2021-01643
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000742
• Device Lot Number: 6303299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP