MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM E; PROSTHESIS, HIP

Catalog Number 010000849

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02018.

Event Description

It was reported that during a hip surgery, after inserting the implanted product, when surgeon checked range of motion, the liner dislodged from the shell.The surgery was finished with a back-up liner.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

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual examination of the liner.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.A g7 neutral e1 liner 32mm e, part # 010000849 from lot 6489077, was returned and evaluated against the complaint.Visual inspection found scratching to be the predominate form of damage to the liner.Small scratching was observed on the outer radius and sidewall of the liner.The inner radius is scraped such that poly material protrudes from the inside of the liner.Indentations made from a removal tool are imprinted in the sidewall and barb.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 NEUTRAL E1 LINER 32MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10061396
• MDR Text Key: 204223593
• Report Number: 0001825034-2020-02017
• Device Sequence Number: 1
• Product Code: LPH
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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 Catalogue Number: 010000849
• Device Lot Number: 6489077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1