MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL; HIP PROSTHESIS

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	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the liner would not assemble with the cup.A second liner was used to complete the surgery.The cup remains implanted.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00-8755-048-00 3113952 allofit it allo-c shell 48/gg.Report source: foreign country: germany.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned device confirms lot etch.Device shows nicks, gouges, and scratches across the liner surfaces from attempted use.Anti rotation scallops and lock feature show deformation and gouges.No other damage noted.Device history record was reviewed and no discrepancies related to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: 32MM I.D. SIZE GG ELEVATED RIM LINER USE WITH 48MM O.D. SIZE GG SHELL
• Common Device Name: HIP PROSTHESIS
• 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: 15196385
• Report Number: 0001822565-2022-02337
• Device Sequence Number: 16681944
• Product Code: JDI
• UDI-Device Identifier: 00889024149670
• UDI-Public: (01)00889024149670(17)270307(10)65310392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/22/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 65310392
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Patient Sex: Unknown