MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2 months post implantation the patient was revised due to dislocation.During surgery, it was determined that the liner was broken.The liner and cup were replaced, and the head remains implanted.There was no reported patient harm.No additional information available.
Additional Manufacturer Narrative
(b)(4).G2: foreign country: spain d10: cat# 00620204820 lot# 64932944 shell porous with multi holes 48 mm cat# unk lot# unk unknown head customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00769.
Event or Problem Description
It was reported a patient had an initial right total hip arthroplasty after a traumatic fall that caused a dislocation and fracture.Subsequently, approximately two months post implantation of the right total hip arthroplasty, the patient fell and experienced a post-operative dislocation.The dislocation was successfully reduced within the emergency department and eighteen days later, a dislocation occurred again with another closed reduction.Six days after the second dislocation, the patient underwent a revision of the cup and liner.During the revision, the liner was found fractured.The procedure was completed without complications.No additional information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: cat# unk lot# unk unknown biolox delta 32+1 head; cat# unk lot# unk unknown screws 25mm x 3; cat# unk lot# unk unknown screws 30mm.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 corrected information.The following sections were corrected: b5;h10.The following sections were updated: b4;g3;h2.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 2648920.

• Brand Name: TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE
• Common Device Name: PROTHESIS, 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: 18838255
• Report Number: 0001822565-2024-00738
• Device Sequence Number: 7439098
• Product Code: LPH
• UDI-Device Identifier: 00889024125513
• UDI-Public: (01)00889024125513(17)271116(10)65625917
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 05/22/2024

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: 00632004832
• Device Lot Number: 65625917
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 05/21/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/20/2024; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 68 KG