MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 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#: 010000661 g7 pps ltd acet shell 48c lot#: 6911325; 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.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: 001825034-2021-02272, 0001825034-2021-02274, 0001825034-2021-02275, 0001825034-2021-02276.

Event 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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 a g7 hi-wall e1 liner 32mm c, part # 010000925 from lot 6891193, was returned and evaluated against the complaint.Visual inspection found pitting on the outer radius of the liner.Gouges are present in the rim and sidewall of the liner.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 Description

No further event information available at the time of this report.

• Brand Name: G7 HI-WALL E1 LINER 32MM C
• Type of Device: 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: 12265955
• MDR Text Key: 264746615
• Report Number: 0001825034-2021-02273
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527010
• UDI-Public: (01)00880304527010(17)251029(10)6891193
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000925
• Device Lot Number: 6891193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 11/22/2021; 03/30/2022
• Supplement Dates FDA Received: 12/03/2021; 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE