MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; 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	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 010000925, g7 hi-wall e1 liner 32mm c, lot#: 6891193.Catalog#: 010000925, g7 hi-wall e1 liner 32mm c, lot#: 6891193.Catalog#: 010000847, g7 neutral e1 liner 32mm c, lot#: 6383693.Catalog#: 010000936, g7 hi-wall e1 liner 36mm f, lot#: 6913032.Catalog#: 51-130100, tprlc 133 fp 12/14 bm so 10.0, lot#: 6762943.Catalog#: 650-0834, delta cer fem hd 032/0mm 12/14, lot#: 3068587.Catalog#: 650-0833, delta cer fm hd 032/-4.0 12/14, lot#: 3061363.Catalog#: 010000997, g7 screw 6.5mm x 20mm, lot#: 6912020.Catalog#: 010000998, g7 screw 6.5mm x 25mm, lot#: 6801958.Catalog#: 010000998, g7 screw 6.5mm x 25mm, lot#: 7012456.Catalog#: 010000999, g7 screw 6.5mm x 30mm, lot#: 6730917.Report source: foreign:(b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02272, 0001825034-2021-02273, 0001825034-2021-02274, 0001825034-2021-02275.
Event or Problem Description
It was reported that the insert did not fit inside the cup, although multiple attempts.As a result, the cup sunk into the acetabulum.The cup has been removed and reinserted after acetabulum reinforcement by the means of screws.A new high-wall insert has been repositioned without success.A third attempt was done by inserting a standard insert, without success.The surgeon decided to definitely remove the cup and to bore the acetabulum to obtain a more equatorial grip.A new high-wall insert has been positioned but it did not fit inside the new cup.In the end, a standard insert has been successfully inserted inside the cup.No adverse events were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Visual and dimensional evaluations could not be performed as no pictures were provided or product returned.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined for items 010000661 (48c shell) and 010000925 (32c liner), 010000847 (32c liner), not seating.The root cause of item 010000661 (48c shell) and 010000936 (36f liner) not seating is directly related to these components not being compatible per the g7 acetabular system surgical technique.Additionally, it is stated in the technique that the color on the liner label should match the color anodized on the rim of the acetabular shell.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A g7 pps ltd acet shell 48c, part # 010000661 from lot 6911325, was returned and evaluated against the complaint.Visual inspection found scratching on the inner radius of the shell.No damage to the locking groove was observed.Upon further review it was discovered that the size f liner was used with a size f cup which is compatible thus the compatibility and root cause determinations have been updated to not determined.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.

• Brand Name: G7 PPS LTD ACET SHELL 48C
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12265959
• Report Number: 0001825034-2021-02276
• Device Sequence Number: 4317780
• Product Code: PBI
• UDI-Device Identifier: 00880304524200
• UDI-Public: (01)00880304524200(17)301207(10)6911325
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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 Model Number: N/A
• Device Catalogue Number: 010000661
• Device Lot Number: 6911325
• 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: 07/23/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 03/30/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 12/03/2021; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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