MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).010000662-g7 pps ltd acet shell 50d-6405788; 010000934-g7 hi-wall e1 liner 36mm d-6760359.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03649; 0001825034 - 2020 - 03651.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 during a hip procedure the surgeon could not get the g7 liner to seat the g7 50mm shell.After trying to seat another liner into the g7 50mm shell with no success the surgeon changed to a 52mm shell that didn¿t seat at the beginning.Subsequently the patient suffered a minor fracture after a heavy blow.The 52mm shell finally seated the 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

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d10; g4; h2; h3; h4; h6 complaint sample was evaluated and the reported event was confirmed.A g7 hi-wall e1 liner 36mm d, part # 010000934 from lot 6122669, was returned and evaluated against the complaint.Visual inspection found a ridge of deformed material at the apex of the liner.The barb has been damaged in 1 location such that a poly strand extends from the barb.The outside of the elevated portion of the liner is gouged/indented.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.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.

• Brand Name: G7 HI-WALL E1 LINER 36MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10641304
• MDR Text Key: 210188347
• Report Number: 0001825034-2020-03652
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000934
• Device Lot Number: 6122669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Age: 57 YR