MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM G; PROSTHETIC, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 08/21/2023

Event Type  Injury  

Event Description

It was reported that during a revision of unknown devices, the doctor noted that the acetabulum was not prepared correctly; therefore, inserted the cup with fixation of four screws.During the attempts of reduction, encountered difficulty and upon delivery of force, led to rotation of the press-fit femoral stem.A curved stem was then placed and as additional reduction attempts were made, the stem also rotated, leading to the stem being cemented.In the process of testing the hip, one event of dislocation occurred; therefore, additional reduction maneuvers were repeated.The procedure was completed and the patient was transported out of the or.After approximately 1 hour, the patient was returned to the or due to dislocation.The liner was revised to a freedom liner and was successfully reduced without dislocation.Subsequently, due to the use of tensile force, the cup detached from the acetabular wall and the patient was hospitalized hip pendent.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: 00625006525 bone screw selftapping 6.5 mm dia.25 mm length lot# j7470733.00625006525 bone screw selftapping 6.5 mm dia.25 mm length lot# j7470734 x3.110010267 g7 osseoti multihole 58mm g lot # 7196532.11-301303 arcos con sz c std 60mm lot #632650.11-301620 item name arcos 20x200mm cyl dist lot # 032610.11-107021 freedom constr hd 36mm t1 +9mm lot # 620700.010000985 g7 freedom const e1 lnr 36mm g lot # 7042237.G2: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02169, 0001825034 - 2023 - 02170, 0001825034 - 2023 - 02172, 0001825034 - 2023 - 02174.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device was discarded.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on evaluation of the provided x-rays.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible loosening of the acetabular cup and associated cement with lateral migration of the acetabular construct.Associated hip dislocation post revision.Loosening of the femoral component.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 Description

There is no update to the prior event description provided.

• Brand Name: G7 HI-WALL ARCOMXL LNR 36MM G
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17744748
• MDR Text Key: 323403267
• Report Number: 0001825034-2023-02173
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526105
• UDI-Public: (01)00880304526105(17)240728(10)6588427
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 010000820
• Device Lot Number: 6588427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male