MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM B; PROSTHESIS, HIP

Catalog Number 010000924

Device Problem Positioning Failure (1158)

Patient Problems Hemorrhage/Bleeding (1888); Osteopenia/ Osteoporosis (2651)

Event Date 02/11/2022

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 -2022 -00491.

Event Description

It was reported that after the intraoperative acetabular was reamed to a 45 and placing the 46mm g7 cup implant, the trial liner was put in.Then, the overall trial was completed and the angle was found to be suitable.Therefore, the 32/b high wall liner was opened as requested by the surgeon.The surgeon first cleaned the soft tissue around the cup edge, checked the acetabular base and then struck the liner.However, the g7 liner did not lock into place.The surgeon cleaned the soft tissue around the cup, the bone bulge, again checked the angle and struck the liner, but it still would not lock.The surgeon repeated checks and cleanups for up to 20 minutes, but the liner would not lock into place.Due to the patient's bone quality problem, the patient ended up with a collapsed acetabulum.A ceramic liner, a g7 cup, and the bottom of the acetabulum was filled with autologous bone and allogeneic bone to complete the procedure.As a result of the malfunction, the procedure was prolonged and caused bleeding to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.B1 correction: complaint was for product problem, no adverse event.One g7 hi-wall e1 liner 32mm b item# 010000924 lot# 6968592 was returned and evaluated.Upon visual inspection there was no visible damage to either the liner or the shell.The liner was sat in the shell and the scallops fit in the grooves of the shell.The devices were not assembled in the lab.A review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot 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 information on the reported event.

• Brand Name: G7 HI-WALL E1 LINER 32MM B
• 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: 13709265
• MDR Text Key: 286847893
• Report Number: 0001825034-2022-00483
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304527003
• UDI-Public: (01)00880304527003(17)260211(10)6968592
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000924
• Device Lot Number: 6968592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 04/13/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 53 KG