MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE E1 INLAY S50 / 28; HIP PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a hip arthroplasty, and subsequently, a revision surgery was performed due to a fall resulting in dislocation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 - medical devices: avantage cemented cup s50; item# p0463050; lot# 0001735517.Unknown head, item# unknown; lot# unknown.G2 - foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 3006946279 - 2023 - 00102, 3006946279 - 2023 - 00104.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified apparent dislocation of the polyethylene liner of the left hip arthroplasty with resulting eccentric position of the femoral head within the acetabular cup.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: AVANTAGE E1 INLAY S50 / 28
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18317023
• MDR Text Key: 330330834
• Report Number: 3006946279-2023-00103
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00887868524967
• UDI-Public: (01)00887868524967(17)280721(10)0001765922
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: P0561E50
• Device Lot Number: 0001765922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 63 KG