MAUDE Adverse Event Report: BIOMET UK LTD. G7 BISPHERICAL SHELL 52E; G7 BISPHERICAL CUPS

Model Number N/A

Device Problems Osseointegration Problem (3003); Patient Device Interaction Problem (4001)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in europe: (b)(6).The product has been requested to be returned to zimmer biomet for investigation.Associated products: medical product: g7 neutral arcomxl lnr 36mm e, catalog #: 010000740, lot #: 3959654.Medical product: biolox delta, ceramic femoral head 36/-3.5, taper 12/14, catalog #: 00877503601, lot #: 2936783.Medical product: fitmore, hip stem, uncemented, offset b (extended)/6, taper 12/14, catalog #: 0100551306, lot #: 2926674.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Clinical study site (b)(4) reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2018.Subsequently, a revision procedure due to inadequate osseointegration of the g7 bispherical cup was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).Additional information received included the following: year of birth: 1963 height of patient: 173cm customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Study site (b)(6) reported that a patient underwent an initial right hip arthroplasty on (b)(6), 2018.Subsequently, a revision procedure due to inadequate osseointegration of the g7 bispherical cup was performed on (b)(6), 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records, complaint history and x-ray review.Thirteen radiographs were provided with (b)(4): two pre-primary radiographs taken on an unknown date, one full-pelvis anteroposterior radiograph with overlaid markers and text dated 2018 (unknown day and month), five full-pelvis anteroposterior radiographs taken on unknown dates, and five hemi-pelvis anteroposterior frog leg radiographs taken on unknown dates.Only the post-surgery radiographs are considered relevant for this assessment.Because the dates on which the provided radiographs were taken are unknown, it is not possible to evaluate them in chronological order to assess changes with time.The inclination angle of the acetabular shell was measured on the provided full-pelvis radiographs where relevant bony landmarks could be seen and was found to be approximately 40 degrees.The provided patient records also state that the inclination angle of the acetabular shells was 39 degrees during the follow-up visits that took place on (b)(6) 2018 and then on (b)(6) 2019; the version of the acetabular shell was marked as neutral, and no radiolucencies were noted.In addition, the provided radiograph dated 2018 reports that the inclination angle of the acetabular shell is 42 degrees.All these measurements are in line with the g7 bispherical surgical technique, which states that the preferred acetabular orientation is 40 degrees inclination and 20 degrees of anteversion, but final acetabular position depends on patient anatomy and may vary slightly with approach.Information provided in etq reports that the patient is male and was born on 1963, therefore he was 55 at the time of primary surgery and 57 at the time of revision.He is 173 cm tall and weighs 80 kg, with a bmi of 26.8 (overweight); he does not smoke; his activity level is unknown.The harris and oxford hip scores provided before and after primary surgery indicate improved hip function at 6 months post-primary surgery.It is reported that the patient did not attend the 1-year follow-up visits; records of the 2-year follow-up visit were not provided.The translation of the revision surgery notes provided in email communication in etq reports that: the joint capsule is massively thickened.Due to the contracted joint and soft tissue situation, the overall procedure is considerably more difficult and prolonged.Evidence of chronic proliferative synovitis.The cup can easily be loosened and removed with the chisel.There is no osseointegration of the cup.The revision of the acetabular shell due to loosening is marked as not related to the device in the provided adverse event form.The information for use included with the g7 bispherical acetabular shell informs that: warnings and precautions: 5.Tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure.Each component must properly press fit into the host bone which necessitates precise operative technique and the use of specified instruments.Bone stock of adequate quality must be present and appraised at the time of surgery.Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals, they cannot be expected to withstand the activity levels and loads of normal, healthy bone and joint tissue.Accepted practices in postoperative care are important.Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure.The patient is to be advised of the limitation of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred.Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear.Possible adverse effects: 4.Loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.The manufacturing history records (mhrs) of the g7 bispherical acetabular shell and associated liner, femoral head and femoral stem have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found 6 (including initiating complaint) similar complaints reported for item #110017332.There were (0) additional complaints against the lot #6225917.Based on the available information, it appears that the reported contracted joint and soft tissue situation may have contributed to the loosening of the acetabular shell.Other contributing factors cannot be discussed without examination of the revised components; these have not been returned to zimmer biomet for evaluation at the time of writing this assessment.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

Study site (b)(6) reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2018.Subsequently, a revision procedure due to inadequate osseointegration of the g7 bispherical cup was performed on (b)(6) 2020.

• Brand Name: G7 BISPHERICAL SHELL 52E
• Type of Device: G7 BISPHERICAL CUPS
• 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: 12126864
• MDR Text Key: 260225059
• Report Number: 3002806535-2021-00297
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110017332
• Device Lot Number: 6225917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2018
• 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: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG