MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 32MM E; 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	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: sweden.Visual examination of the returned product identified damage / witness marks on the scallops of the backside of the high wall feature.Complaint sample was evaluated.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to the user failing to follow instructions.Within the surgical technique, the only instructions for repositioning are specific to the provisional liner.Test repositioning should not have occurred with the final implant.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.The event was initially reported under the wrong mfr number: 0001825034-2022-00985.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 was loose upon implantation.Another liner was used to complete the procedure.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

• Brand Name: G7 LONGEVITY HIGH WALL 32MM E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15175069
• Report Number: 0001822565-2022-02290
• Device Sequence Number: 20114120
• Product Code: JDI
• UDI-Device Identifier: 00889024519275
• UDI-Public: (01)00889024519275(17)281023(10)65256087
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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 Model Number: N/A
• Device Catalogue Number: 20123205
• Device Lot Number: 65256087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• 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: 07/28/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male