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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: 010000924-g7 hi-wall e1 liner 32mm b-6854139.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -02898.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 or Problem Description
It was reported during an initial hip arthroplasty the surgeon could not get the first g7 highwall liner to seat.Surgeon had to ensure the interior of the shell is dry and free of debris, overhanging soft tissue was removed.Surgeon manually placed the liner into the shell, ensuring the scallops were correctly aligned with the recessed areas on the shell.Applying manual pressure to the dome region to provisionally secure the liner in place by lightly engaging the scallops.Utilizing the appropriately sized g7 ball impactor, placed the tip of the impactor on the dome of the liner with the handle perpendicular to the face of the shell.After several attempts, surgeon opened the second liner.Multiple attempts with same technique, surgeon was finally able to get second liner to seat.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One g7 hi-wall e1 liner 32mm b item# 010000924 lot# 6771723 approximate age of 1 year was returned and evaluated.Upon visual inspection the device has indentations on the outer radius along with indentations on the locking feature.There is no other visible damage to the device.The device was found to be conforming to print specifications during manufacturing.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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 or Problem Description
No additional information on the reported event.

• Brand Name: G7 HI-WALL E1 LINER 32MM B
• Common Device Name: 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: 12671557
• Report Number: 0001825034-2021-02897
• Device Sequence Number: 1454000
• Product Code: PBI
• UDI-Device Identifier: 00880304527003
• UDI-Public: (01)00880304527003(17)250318(10)6771723
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2025
• Device Model Number: N/A
• Device Catalogue Number: 010000924
• Device Lot Number: 6771723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female