MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL LONGEVITY XLPE 0 DEGREE FACE ANGLE 36MM I.D. LINER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure on an unknown date.Subsequently, the patient was revised due to dislocation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0660 lot# 3185359 delta ceramic head 36mm -3 t1.Cat# 11-301303 lot# 65698547 arcos come body c 60mm.Cat# 11-300820 lot# 313970 arcos 20x150mm spl tpr dist.Cat# 00662406540 lot# 65655248 bone screw self-tapping 40 mm length 6.5 mm dia.G2: foreign: australia.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: g3; h2; h3; h6.Visual examination of the provided pictures identified the cone body and head with biodebris and nicks and gouges on the taper surface.No pictures were provided of the liner and no products were returned.Further evaluation could not be performed based on the provided images alone.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is a dislocation on the spot view.Bone quality is osteopenic.No loosening or abnormal radiolucency.There is malalignment with dislocation on the spot ap view.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 or Problem Description
No further information at the time of this report.

• Brand Name: TRABECULAR METAL LONGEVITY XLPE 0 DEGREE FACE ANGLE 36MM I.D. LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19514212
• Report Number: 0001822565-2024-01960
• Device Sequence Number: 4035996
• Product Code: JDI
• UDI-Device Identifier: 00889024129115
• UDI-Public: (01)00889024129115(17)280103(10)65515563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 00710505836
• Device Lot Number: 65515563
• Was Device Available for Evaluation?: No
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male