MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; HIP PROSTHESIS

Catalog Number 650-0662

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Respiratory Failure (2484)

Event Date 08/26/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial left total hip arthroplasty.One year and three months post implantation, the head and stem were revised due to loosening of the femoral component with failure to osteointegrate.Five years and five months post the first revision procedure, the patient was revised for a second time due to a fracture of the revision stem with complicated extraction via extended trochanteric osteotomy.After the second revision, the patient experienced recurrent dislocations requiring closed reduction under anesthesia.A third revision was planned but delayed due to difficulty extubating the patient and the concurrent onset bilateral pulmonary embolisms.After the patient¿s pulmonary function and anticoagulation measures were stabilized, the revision occurred during which, multiple hematomas were evacuated from the joint, and posterior instability was confirmed on exam.Upon replacing the acetabular shell, anteversion was increased by 15 degrees.A new constrained head and liner were placed within the shell, and the revision stem was retained.Postoperatively, the patient demonstrated slow but steady progress with intensive physical therapy.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).D10 - associated medical devices: liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell; item# 00630505636; lot# 63687030.Shell porous with cluster holes 56 mm o.D.; item# 00620005622; lot# 62954811.Bone screw self-tapping 6.5 mm dia.50 mm length; item# 00625006550; lot# 63003489.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.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18835517
• MDR Text Key: 336853199
• Report Number: 3002806535-2024-00080
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)301222(10)3053017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 650-0662
• Device Lot Number: 3053017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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 H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Race: White