MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 28MM F; PROSTHESIS HIP

Catalog Number	010000801
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted.Concomitant medical devices: item# 110017104/ g7 finned 4 hole shell / lot # 6746444; item # 010000811/ g7 hi-wall arcomxl lnr /lot # 6744972.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports 0001825034 -2021 -01106, 0001825034 -2021 -01105.
Event or Problem Description
It was reported that during an initial procedure, the surgeon was unable to insert the polyethylene liner into the acetabular cup.The surgeon then tried a backup liner and it was also unsuccessful.The g7 acetabular cup was replaced with a mallory head acetabular cup.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.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 visual examination of the returned product/provided pictures identified liner 6744972 has scuffing near the scallop location but no further damage to the device.Liner 6617746 locking feature has visible shaving.There was no visible damage to the returned shell.The shell and liners were returned separate and no attempt was made to combine them in the lab.Provided video shows attempted insertion of both liners into shell, liners did not seat properly in shell.The video was not taken during the surgery.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event 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 further event information available at the time of this report.

• Brand Name: G7 HI-WALL ARCOMXL LNR 28MM F
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11684461
• Report Number: 0001825034-2021-01101
• Device Sequence Number: 19604169
• Product Code: KWZ
• UDI-Device Identifier: 00880304525931
• UDI-Public: (01)00880304525931(17)240821(10)6617746
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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: 08/21/2024
• Device Catalogue Number: 010000801
• Device Lot Number: 6617746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 80