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

Catalog Number	00625006540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Scar Tissue (2060); Sepsis (2067); Septic Shock (2068); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 010000662 lot# 7006286 g7 pps ltd acet shell 50d.Cat# 11-300814 lot# 66095192 arcos 14x150mm spl tpr dist.Cat# 11-301310 lot# 66195608 arcos con sz a hi 50mm.Cat# 650-0662 lot# 3144899 delta ceramic fem hd.Cat# 00223200518 lot# 64613801 cable.Cat# 110034355 lot# ax48ca0604 refobacin bc r 1x40 us.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.
Event or Problem Description
It was reported that approximately two months post-hip procedure, the patient presented with septic shock due to mrsa infection in the hip.They had fevers, difficulty walking, swelling, abscess, and positive cultures for mrsa and septic shock.The head was exchanged in an i&d procedure before the stage one revision one month later.Op records note purulent fluid, large fascial dehiscence.All components were replaced with a cement spacer during stage one without complications.The stage two revision took place four months later.Attempts have been made and no further information has been provided.

• Brand Name: TRILOGY
• 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: 25183690
• Report Number: 0001822565-2026-01586
• Device Sequence Number: 16141270
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)331014(10)J7629854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/15/2026

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: 00625006540
• Device Lot Number: J7629854
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG