MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 032/-4.0 12/14; STERILE TOTAL HIP ARTHROPLASTY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Medical product: ringloc-x e1 std 50/32mm 23, catalog #: ep-043250, lot #: 3206420.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left hip arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to a ceramic head fracture was performed on (b)(6) 2021.The patient helped return a person who had fallen over to his feet.In doing so, he immediately felt a sudden shooting pain in the left hip.On (b)(6) 2021, the patient first presentation at a local orthopaedic surgeon's practice when a ceramic head fracture was determined.On (b)(6) 2021, the diagnosis was confirmed by means of x-rays and ct scans.Immediate immobilisation and stationary admission for surgical treatment, in particular salvage of the ceramic fragments.On (b)(6) 2021, the patient was revised.Not all fragments could be completely recovered.

Event Description

It was reported that a patient underwent an initial left hip arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to a ceramic head fracture was performed on (b)(6) 2021.The patient helped return a person who had fallen over to his feet.In doing so, he immediately felt a sudden shooting pain in the left hip.On (b)(6) 2021, the patient first presentation at a local orthopaedic surgeon's practice when a ceramic head fracture was determined.On (b)(6) 2021, the diagnosis was confirmed by means of x-rays and ct scans.Immediate immobilisation and stationary admission for surgical treatment, in particular salvage of the ceramic fragments.On (b)(6) 2021, the patient was revised.Not all fragments could be completely recovered.

Manufacturer Narrative

(b)(4).Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Refer action item #ai553245: nine radiographs were provided with (b)(4) for analysis: one anteroposterior (ap) radiograph taken on (b)(6) 2014, two radiographs taken on (b)(6) 2014 (one ap and one lateral), two radiographs taken on (b)(6) 2015 (one ap and one lateral), two radiographs taken on (b)(6) 2021 (one ap and one lateral), two radiographs taken on (b)(6) 2021 (one ap and one lateral).The inclination angle of the acetabular shell in the postoperative ap radiograph taken on (b)(6) 2014 is approximately 57.7 degrees, which is higher than the surgical inclination of 45 degrees mentioned in the operative report from the primary surgery.The exceed abt acetabular system surgical technique recommends a surgical inclination angle of 40 to 45 degrees.It is possible that this high inclination angle may have contributed to the fracture of the femoral head due to unusual load distribution and elevated stresses.However, this cannot be confirmed with the available information.Both pre-revision ap and lateral radiographs confirm the fracture of the biolox delta femoral head.The manufacturing history records (mhrs) for the biolox delta femoral head and custom-made schneppendahl ha primary hip stem have been checked and verify that these components were manufactured and sterilized in accordance with the applicable specifications.Based on the information provided in the zimmer biomet product experience report (zper) associated with (b)(4), the patient is 57 years old female with a weight of 61kg and a height of 166 cm, thus having a bmi of 22.14 (healthy weight).The operative report from the revision surgery mentions that corrosion at the head stem interface may have been a contributing factor to the fracture of the femoral head.This cannot be confirmed without provision of the revised components for examination.The instructions for use provided with the biolox delta femoral head provide the following relevant information: warnings and precautions: clinical outcome may be affected by component positioning.Proper placement of the implant should take into consideration individual patient anatomy as well as surgeon preference.The surgical technique sets forth suggested guidelines for placement of the implant including inclination and anteversion.Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.Improper preoperative or intra-operative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture, and/or excessive wear.Thoroughly clean and dry taper prior to attachment of the modular head component to avoid crevice corrosion and improper seating.Patient warnings: the patient is to be cautioned to govern activities, protecting the joint replacement from unreasonable stress conditions.Excessive activity, failure to control body weight.And trauma affecting the joint replacement have been associated with premature failure of the reconstruction by loosening, fracture and/or wear of the implants [¿] the patient must be warned that the device does not replace normal healthy bone, and that the implant can break or be damaged as a result of excessive load bearing or trauma.Possible adverse effects: fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight.Fretting and crevice corrosion can occur at interfaces between components.The primary reason for the fracture of the biolox delta femoral head cannot be established with the available information.However, contributing factors may include suboptimal acetabular cup positioning and the incident where the patient helped someone who had fallen.Additional contributing factors such as corrosion cannot be confirmed without provision of the revised components.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text: device not returned.

Event Description

It was reported that a patient underwent an initial left hip arthroplasty.Approximately, seven years later a revision procedure due to a ceramic head fracture was performed.The patient helped return a person who had fallen over to his feet.In doing so, he immediately felt a sudden shooting pain in the left hip.The patient first presentation at a local orthopaedic surgeon's practice when a ceramic head fracture was determined.The diagnosis was confirmed by means of x-rays and ct scans.Immediate immobilisation and stationary admission for surgical treatment, in particular salvage of the ceramic fragments.The patient was revised but not all fragments could be completely recovered.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information as the product has been returned for evaluation.The following sections were updated: a biolox delta ceramic head and an exceed abt e1 ringloc-x acetabular liner were received for analysis, after the head fractured after approximately 7 years and 4 months in service when the patient made a sudden awkward movement.Visual examination of the fractured head shows uneven metal transfer marks within the taper, as well as numerous metal transfer marks on all surfaces, likely from contact with the metal stem, acetabular shell and/or from contact with instruments during removal.The received e1 liner presented severe wear and damage from contact with ceramic fragments and with the femoral stem taper.Evaluation of the provided radiographs showed that the acetabular shell was positioned at about 57 degree inclination, compared to the recommended 40 degree to 45 degree.The manufacturing history records of the biolox delta head, exceed abt e1 ringloc-x acetabular liner and associated femoral stem have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.The root cause of the ceramic head fracture could not be determined in this instance.It is possible that suboptimal seating of the biolox delta head, suboptimal acetabular cup positioning, high stresses due to the patient¿s unusual movement and her history of hip dysplasia, exostosis and poor bone stock quality may have been contributing factors.The adverse wear observed on both received components may have been generated between the time the ceramic head fractured and revision surgery.

• Brand Name: DELTA CER FM HD 032/-4.0 12/14
• Type of Device: STERILE TOTAL HIP ARTHROPLASTY
• 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: 12196259
• MDR Text Key: 262465486
• Report Number: 3002806535-2021-00318
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: N/A
• Device Catalogue Number: 650-0833
• Device Lot Number: 3114985
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 04/01/2022
• Supplement Dates FDA Received: 11/02/2021; 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2013
• Is the Device Single Use?: No
• 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
• Patient Weight: 61 KG