MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM I.D. SIZE GG NEUTRAL LINER USE WITH 48MM O.D. SIZE GG SHELL; PROSTHETIC, 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	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 00-8757-048-01 48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners lot number 65253343.00-8851-008-32 32mm i.D.Size gg neutral liner use with 48mm o.D.Size gg shell lot number: 65461866.G2: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 : device in process to return.
Event or Problem Description
It was reported that the liner could not be seated.There was a 0-15 minute delay to obtain a new liner to complete the procedure.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
Visual examination of the returned product identified indentations on the rim face, taper wall, and near the anti rotation scallops from attempted implant.Inner spherical surface shows nicks and scratches.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot 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
There is no update to the prior event description provided.

• Brand Name: 28MM I.D. SIZE GG NEUTRAL LINER USE WITH 48MM O.D. SIZE GG SHELL
• Common Device Name: PROSTHETIC, 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: 17119076
• Report Number: 0001822565-2023-01554
• Device Sequence Number: 6649610
• Product Code: JDI
• UDI-Device Identifier: 00889024154919
• UDI-Public: (01)00889024154919(17)270821(10)65596315
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200823
• 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,Followup
• Report Date (Section B): 08/16/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00885100828
• Device Lot Number: 65596315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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: Unknown
• 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 Sex: Prefer Not To Disclose