MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY NEUTRAL 36MM F; PROSTHESIS HIP

Catalog Number	20103606
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual evaluation of the returned device noted the following: gouges on the outer spherical surface.The anti-rotation tabs and locking features exhibited damage.No other damages were noted.Inspection of the returned device revealed 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.Concomitant medical devices: part # unknown / unknown head/ lot # unknown; part #unknown / unknown stem/ lot # unknown; part #unknown / unknown cup/ lot # unknown.
Event or Problem Description
It was reported during an initial hip arthroplasty the liner did not seat fully in cup.Surgery was completed with a backup liner.The exchange was done without issue.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 LONGEVITY NEUTRAL 36MM F
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11663578
• Report Number: 0001822565-2021-01066
• Device Sequence Number: 3127764
• Product Code: LPH
• UDI-Device Identifier: 00889024518759
• UDI-Public: (01)00889024518759(17)200719(10)64809010
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 04/13/2021

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: 07/19/2025
• Device Catalogue Number: 20103606
• Device Lot Number: 64809010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 04/14/2021
• 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