MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; 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	02/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00625006530 ¿ bone screw ¿ 64608856, 00625006530 ¿ bone screw - j6686486, 00625006520 ¿ bone screw - 63010006, 110010244 ¿ g7 shell ¿ 6644426, 51-100070 ¿ taperloc stem - 6636237, 12-115122 ¿ biolox ceramic head - 6598562.Reported event was unable to be confirmed due to limited information provided by the customer.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.Product location is unknown.
Event or Problem Description
It was reported that during a hip procedure, the poly liner would not seat properly.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11664361
• Report Number: 0001825034-2021-01060
• Device Sequence Number: 11543643
• Product Code: PBI
• UDI-Device Identifier: 00880304526426
• UDI-Public: (01)00880304526426(17)240725(10)6598562
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 07/25/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000857
• Device Lot Number: 6598562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2020
• 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