MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEU +5MM ARCOMXL LNR 36MM G 36MM G; HIP PROSTHESIS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Item #unknown, g7 cup lot #unknown.Foreign country (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a surgeon could not get the liner to seat properly in the shell during an initial total hip arthroplasty (tha).A 36 neutral liner was used instead with no issues to complete the procedure.Additional information was requested, however no information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi : (b)(4).Reported date should be voided as this device was never fully implanted into the patient.Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows the locking feature is damaged.The scallops also show damage.Dhr was reviewed and no discrepancies were found.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.

Event Description

No additional event information to report at this time.

• Brand Name: G7 NEU +5MM ARCOMXL LNR 36MM G 36MM G
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8497183
• MDR Text Key: 141388891
• Report Number: 0001825034-2019-01464
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K142882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: N/A
• Device Catalogue Number: 110017187
• Device Lot Number: 6383931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: MEDICAL PRODUCTS.