MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported during a knee arthroplasty that the implant would not lock into place.No adverse events have been reported as a result of the malfunction.A delay of greater than 30 min has occurred in surgery.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional and corrected information.

Manufacturer Narrative

(b)(4).The reported event is confirmed.Product was returned; therefore, the visual inspection of the liner found multiple forms of damage.The barb was scraped leaving a rough edge.The side wall of the liner was heavily gouged and scratched.The scallops had an indentation which appeared to be caused by the grooves of a mating shell.The outer radius also exhibited a small amount of pitting and surface scratches.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

It was reported during a total hip arthroplasty, that the liner would not seat into the acetabular shell.A delay of greater than 30 min occurred in surgery while attempting to seat the liner.No additional patient consequences were reported.

• Brand Name: G7 10 DEG E1 LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7206811
• MDR Text Key: 98013845
• Report Number: 0001825034-2018-00371
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000897
• Device Lot Number: 6155252
• Other Device ID Number: (01) 0 0880304 52677 8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization