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

Catalog Number	110010244
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the procedure, the shell was broken upon impaction.There was no harm or health impact to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.One g7 osseoti 3 hole shell 52mm e item# 110010244, lot# 66160469 was returned and evaluated.Upon visual inspection the lip of the shell has separated from the rest of the shell.There is no other visible damage to the shell.The event is confirmed based on the evaluation of the returned product.(b)(4).Fracture analysis showed suspected crack initiation near the outer diameter at the osseoti lattice and solid substrate interface of the cup.Cracks appeared to have propagated towards the inner diameter.Suspected multiple crack initiation sites showed powder particles and pores that appeared to have particles pulled out.Fracture surface showed several individual powder particles and agglomerates throughout the fracture ranging from 5 microns to 50 microns.Mixed mode of ductile and brittle overload fracture identified for the most part of cup, which is unusual for a ti-6al-4v alloy.The brittleness on the fracture indicates a fast fracture and no yielding of the material (lack of shearing or sheared dimples on the fracture) during impaction.The brittleness observed on the fracture surface is suspected to be an indicative of either embrittlement in the powder caused by interstitial elements such as o, or h, or n, or due to a presence of pre-existing crack that was formed during the build.A band of pure ductile overload fracture with normal dimples identified near the inner diameter at one end of the crack, suggesting that the pre-existing crack did not propagate all the way to the inner diameter and the final rupture was not a fast fracture.The root cause of the reported issue can be attributed to a manufacturing deficiency.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 or Problem Description
No addtiional event information to report at this time.

• Brand Name: G7 OSSEOTI 3 HOLE SHELL 52MM E
• Common Device Name: 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: 18587678
• Report Number: 0001825034-2024-00161
• Device Sequence Number: 7140208
• Product Code: LPH
• UDI-Device Identifier: 00880304544192
• UDI-Public: (01)00880304544192(17)330929(10)66160469
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110010244
• Device Lot Number: 66160469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female