MAUDE Adverse Event Report: . G7 NEUTRAL E1 LINER 36MM F; PROSTHESIS HIP

Catalog Number	010000858
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product will not be released by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).
Event or Problem Description
It was reported that upon impacting the liner the surgeon noted it did not seat properly.The liner was removed and the surgeon checked that the screws were properly seated in cup.Surgeon noted that nothing was in the cup that would not allow the liner to engage correctly the surgeon attempted to seat the liner again; however, the liner would still not seat.The surgeon inspected the liner and noted it was damaged.A new liner was impacted into the cup without any issues.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: g3; h2; h3; h6 corrected: h6 impact code.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 NEUTRAL E1 LINER 36MM F
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12162810
• Report Number: 0001825034-2021-02081
• Device Sequence Number: 3530025
• Product Code: PBI
• UDI-Device Identifier: 00880304526433
• UDI-Public: (01)00880304526433(17)250304(10)6760356
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/10/2021

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: 03/04/2025
• Device Catalogue Number: 010000858
• Device Lot Number: 6760356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1