MAUDE Adverse Event Report: Zimmer Biomet, Inc. Femoral Head; Prosthesis, hip

Catalog Number	802202803
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision approximately 3 days post-implantation due to dislocation.A patient was involved requiring revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 11-165218, lot# 67193566.G2: foreign ¿ event occurred in australia.H6: proposed component code: mechanical (g04) - head.The customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policies.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• 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.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50082117
• Report Number: 0001822565-2026-02697
• Device Sequence Number: 10320393
• Product Code: LPH
• UDI-Device Identifier: 00889024498792
• UDI-Public: (01)00889024498792(17)360105(10)3260827
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 802202803
• Device Lot Number: 3260827
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Sex: Female