MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 52MM O.D. SIZE II POROUS UNCEMENTED WITH MULTI-HOLES SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown stem, lot #: unknown.Item #: unknown, unknown liner, lot #: unknown.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately five months post implantation due to pain, loosening of implant, and implant migration.Optimal positioning and augmentation with screw can be seen on immediate post op film.Follow up x-rays at six weeks post op showed changed in cup position secondary to failure of ingrowth and loosening.Patient started experiencing increasing hip pain at five weeks post op.Revision was finally done after a trial of conservative management with protected weight bearing did not help ingrowth of cup.Patient continued to experience worsening pain.Cup was revised.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A shell and a screw were returned for evaluation.Shell was returned with liner fully seated and fractured screw head still in the shell hole.Screw head was not removed for evaluation.Shell shows nicks, gouges, and scratches to the outer diameter of the face.Bio debris discoloration is noted to the fiber metal surface.Visual review of the fractured bone screw shows screw has fractured.(2) fractured pieces were returned.Proximal screw head remains in the shell hole between the liner and shell.Distal screw threads shows fractured surface and extraction damage including nicks, gouges, and deformation.The screw was sent to sem for further analysis.The analysis identified bone screw sample could not be determined due to the lack of fracture artifacts.Elemental analysis of the bone screw sample showed that it is consistent with ti-6al-4v alloy.Radiographs were provided and reviewed by a health care professional.Review of the available records identified incomplete integration of the acetabular cup with the subjacent bone with subsidence of the acetabular cup and likely acetabular cup screw breakage.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: 52MM O.D. SIZE II POROUS UNCEMENTED WITH MULTI-HOLES SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13731922
• Report Number: 0001822565-2022-00702
• Device Sequence Number: 17299150
• Product Code: LPH
• UDI-Device Identifier: 00889024150188
• UDI-Public: (01)00889024150188(17)301031(10)64869971
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00875305202
• Device Lot Number: 64869971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female