MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER LNR 32MM D; HIP PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: g7 bonemaster ltd acet shl 50d; item# 010000702; lot# 7353727.36mm i.D.Size d neutral liner; item# 30103604; lot# 65578944.Avenir muller stem 3 standard; item# 01.06010.004; lot# 3147518.G2 - foreign: luxemburg.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a total hip arthroplasty, and approximately 4 months later a revision surgery was performed due to pain and fracture of the ceramic liner.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned ceramic head and the photos taken of it identified a large region of metal transfer on the bearing surface which suggests articulation of the component against the metallic acetabular shell after fracture of the liner.Examination of the fractured liner images shows metal transfer marks, likely from contact with the acetabular shell and from contact with instruments during removal.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.Significant findings include that the single ct image demonstrates a fractured insert which is inferiorly displaced and with metal-on-metal contact of the prosthetic femoral head and superior acetabular cup.The entire femoral implant is not included on the image.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.

• Brand Name: BIOLOX DELTA CER LNR 32MM D
• 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: 17697055
• MDR Text Key: 322800347
• Report Number: 3002806535-2023-00301
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 05019279494507
• UDI-Public: (01)05019279494507(17)320531(10)3101938
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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: 11/30/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110003621
• Device Lot Number: 3101938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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 Sex: Female