MAUDE Adverse Event Report: Zimmer Biomet, Inc. ECHO HIP FX LAT FEMORAL 9MM; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Catalog Number	12-151409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently, the patient underwent a head and liner exchange approximately 2 years and 4 months post-implantation due to trunnionosis and metal-related pathology.The patient reported ongoing extreme pain and swelling following the revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Proposed component code: mechanical (g04) - stem.D10: cat#: 5036966, lot#: 96771058, palacos cement x2, cat#: 650-1057, lot#: 3236263, cer bioloxd option hd 36mm, cat#: 650-1068, lot#: 3213292, cer option type 1 tpr sleve +6.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: ECHO HIP FX LAT FEMORAL 9MM
• Common Device Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
• 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 ; +1(574)526-0384
• MDR Report Key: 50274685
• Report Number: 0001825034-2026-02387
• Device Sequence Number: 10588122
• Product Code: KWA
• UDI-Device Identifier: 00880304520295
• UDI-Public: (01)00880304520295(17)330628(10)65993051
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 12-151409
• Device Lot Number: 65993051
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 Narrative.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 170 LB