MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MONOBLOCK SHELL INSRTR; HIP INSTRUMENT

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

It was reported that during a hip procedure, the shell inserter could not be disengaged from the shell.Attempts to unscrew the handle led to the implant spinning and loss of primary fixation.The shell was removed from the patient and a new shell and inserter were used to complete the surgery.There was no reported harm or injury to the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for the 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 -2022 -01453.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the shell to be attached to the inserter as reported.No further conclusions could be made about it's function or threads on the shell or inserter.A review of the device history records identified no deviations or anomalies during manufacturing.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

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No additional event information to report at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4(udi); g3; h2; h3; h4; h6 one g7 str monoblock shell insrtr was returned and evaluated.Upon visual inspection there are marks on the strike plate and scuffing on the shaft and guard.The tip of the threads were bent so no further testing was done.A review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: G7 STR MONOBLOCK SHELL INSRTR
• Type of Device: HIP INSTRUMENT
• 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: 14756387
• MDR Text Key: 294423606
• Report Number: 0001825034-2022-01454
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00880304532694
• UDI-Public: (01)00880304532694(11)190327(10)785070
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 110003450
• Device Lot Number: 785070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• Is the Device Single Use?: No
• 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 Age: 70 YR
• Patient Sex: Male