MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 36MM H; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Photographs of a g7 liner were provided.Visual evaluation identified the following: there is damage, most likely due to insertion attempts, around the rim of the liner.No other damages were noted and no further evaluation can be performed with the images provided.Photographs were evaluated and the reported event was not confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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
It was reported that during an initial hip arthroplasty, the liner would not seat into the cup.Another liner was used to complete the surgery no adverse events have been reported as a result of the malfunction.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: b4, b5, d4 (udi number) d9, g3, h1, h2, h3, h10.The reported liner was returned and visual evaluation identified the following: there were damages to the rim feature, antirotation tabs, and the backside of the locking features that most likely occurred during implantation attempts.No other damage was noted.Complaint sample was evaluated and the reported event was not confirmed.Evaluation of the returned product does not change the final conclusions of the previous investigation.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 trend.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 LONGEVITY HIGH WALL 36MM H
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11699661
• Report Number: 0001822565-2021-01079
• Device Sequence Number: 3635105
• Product Code: JDI
• UDI-Device Identifier: 00889024519350
• UDI-Public: (01)00889024519350(17)301124(10)64611121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 20123608
• Device Lot Number: 64611121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAT#010000668 G7 SHELL LOT#6469870; CAT#010000668 G7 SHELL LOT#6469870