MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD; PROSTHESIS, HIP

Catalog Number	802203202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ norway.H6: proposed component code - mechanical: head.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.
Event or Problem Description
It was reported that the patient suffered a hip dislocation after falling to the floor.Unknown if a revision took place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 approximately one day post-implantation, the patient underwent a left hip open repositioning due to dislocation following a syncope event and fall.The torn joint capsule was repaired and joint repositioned without complications.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h4; h6; h10.The following sections were corrected: d5.Product has not been returned.No product evaluation was able to be completed.Root cause of the reported event is not device related.It was reported that a patient fell during a syncopal episode one day postop causing a dislocation and tear of the capsule repair.During an open reduction and repair of the capsule, all components were retained indicating no implant concern regarding form, fit, or function.Syncope occurs when blood pressure drops causing a lack of oxygen or blood flow to the brain resulting in a temporary loss of consciousness.This often happens with a sudden change in movement (such as abrupt standing), medication side effects, shallow breathing, and other benign findings.As the complaint indicates, no implant concerns were found with no further complications reported.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: FEMORAL HEAD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 21688801
• Report Number: 0001822565-2025-00749
• Device Sequence Number: 18336389
• Product Code: LPH
• UDI-Device Identifier: 00889024498839
• UDI-Public: (01)00889024498839(17)340924(10)3216810
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: Lay User/Patient
• Device Catalogue Number: 802203202
• Device Lot Number: 3216810
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 07/23/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/21/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Unknown