MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 52E; PROSTHETIC, HIP

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 11/04/2022

Event Type  Injury  

Event Description

It was reported that the pt fell day 4 post op in her nursing home and dislocated her hip.An attempt at a closed reduction was unsuccessful, but did cause acetabular shell to move.Surgery was performed to revise the dislocation and loosened shell.During revision procedure it was found that the 28mm head had dissociated from the articulating 42mm e1 bearing.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mdr328235 and mdr328238.Reporter source: foreign: australia.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, as supplemental medwatch will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: expiration date and udi.Visual examination of the provided pictures identified a poly bearing, metal liner, metal shell and metal head exhibiting bio debris.No other information could be obtained from the image.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impression: right hip arthroplasty dislocation and possible acetabular implant loosening.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 BONEMASTER LTD ACET SHL 52E
• 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: 15845435
• MDR Text Key: 304128150
• Report Number: 0001825034-2022-02663
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304524620
• UDI-Public: (01)00880304524620(17)320612(10)7268284
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K911684
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000703
• Device Lot Number: 7268284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female