MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 28 MM I.D.; PROTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Joint Dislocation (2374)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: canada.D10: cat#: 6200-52-22, lot#: 61237861 shell porous with cluster holes 52 mm o.D.Cat#: 7711-11, lot#: 61487763 femoral stem 12/14 neck taper plasma sprayed press-fit.Cat#: 8018-28-02, lot#: 61558147 femoral head.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2024-00060, 0001822565-2024-00846, 0002648920-2024 -00061.

Event Description

It was reported that approximately 9 years post implantation of a right total hip arthroplasty, the patient was bending down and had a sudden posterior right hip dislocation.A reduction was attempted in the emergency department; however, the reduction was unsuccessful, and the patient had to have a closed reduction in the operating room.After the closed reduction, the patient reported chest pain that was worse with deep breathing.It was determined that the patient had bilateral pulmonary embolism.The patient was placed on supplemental oxygen and anticoagulation therapy.Three weeks later the patient was sitting applying lotion and dislocated her hip for a second time.The patient was reduced in the emergency department.No additional information.

• Brand Name: TRILOGY LONGEVITY LINER 20 DEGREE ELEVATED RIM 28 MM I.D.
• Type of Device: 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: 18879560
• MDR Text Key: 337402516
• Report Number: 0001822565-2024-00845
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K990135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 00632005028
• Device Lot Number: 61312811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG