MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E; PROSTHESIS, HIP

Model Number N/A

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000935 ¿ g7 liner ¿ 7252633; 00-8018-036-05 ¿ femoral head ¿ 37220430; unknown stem ¿ unknown part and lot.Report source australia.Product will not be returning to zimmer biomet for the investigation as the hospital did not approve of the return.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip procedure, the surgeon observed the cup was potentially not stable and was confirmed on post operative x-ray.The surgeon commented that there was possibly excessively reamed through the acetabular floor.Through post-operative monitoring, it was observed that the cup had migrated superiorly and the patient underwent a revision surgery approximately 16 days later.During the procedure, all components were removed and replaced without complication.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: possible early loosening of the acetabular cup.Acetabuli protrusio of the acetabular cup is present.There is horizontal orientation of the cup as well.Visual examination of the provided pictures identified no damage of wear can be seen on the components.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Type of Device: PROSTHESIS, 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: 16146553
• MDR Text Key: 307175183
• Report Number: 0001825034-2023-00054
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)320307(10)7201793
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140669
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 110010244
• Device Lot Number: 7201793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male