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

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10641304
• Report Number: 0001825034-2020-03652
• Device Sequence Number: 14097752
• Product Code: PBI
• UDI-Device Identifier: 00880304527096
• UDI-Public: (01)00880304527096
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Patient Age: 57 YR