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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/31/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat #: ep-200148 / act artic e1 hip brg 28x42mm / lot #: 620190.Cat #: 00801802803 / femoral head sterile product do not resterilize 12/14 taper / lot #: 64719808.G2: australia.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 will be submitted.

Event Description

It was reported a patient underwent a hip revision approximately three years post implantation due to a disassociation and fracture after experiencing a fall.The head and bearing were removed and replaced.Attempts have been made and no further information is available.

• Brand Name: UNKNOWN LINER
• Type of Device: 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: 19191105
• MDR Text Key: 341136329
• Report Number: 0001822565-2024-01417
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG