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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).Report source: (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an right knee arthroplasty.Subsequently, a revision procedure due to cup loosening was performed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.G3: report source, foreign - event occurred in switzerland.Product has been received to zimmer biomet for investigation.Once the investigation is completed, a supplemental final mdr report will be submitted.

Event Description

It was reported that a patient underwent a total hip arthroplasty.Subsequently, a revision procedure due to cup loosening was performed.

Event Description

It was reported that a patient underwent a total hip arthroplasty.Subsequently, a revision procedure due to cup loosening was performed.

Manufacturer Narrative

(b)(4).G3: report source, foreign - event occurred in switzerland.Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.Product evaluation review: a g7 bispherical acetabular shell was returned for evaluation, assembled with the corresponding e1 liner.Visual examination of the explanted acetabular shell showed few small fragments of bone tissue attached to its surface.The e1 liner showed scratches and damage on the rim, likely caused by an instrument during revision and/or due to attempts to separate the liner from the metal shell.Post-primary and post-revision radiographs were provided in the corresponding surgical reports.An inclination angle of 47.9 was measured for the acetabular shell from the postprimary ap radiograph.The g7 bispherical surgical technique 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.Final orientation of the acetabular implant is also dictated by the amount of version of the femoral implant (i.E., greater anteversion of the acetabular component may be required in the case of a retroverted stem).Although it has been observed previously that the radiographic inclination angle can be approximately 5 degrees more than the intra-operative inclination angle, the inclination of the bispherical acetabular shell appears to be slightly higher than recommended.Radiolucency of the acetabular shell could be observed around the zone 3 (charnley and delee system) in the immediate post-revision ap radiograph.However, this does not provide any information on loosening of the primary acetabular shell.Post-primary and pre-revision radiographs are required to evaluate the loosening of the primary acetabular shell.-the mhr related to the involved products have been reviewed and do not show any non-conformity, rejection or concession that could be related to the reported event.-a review of the complaint database over the last 3 years has found two similar complaints for the item 110017332.-the root cause of the g7 bispherical acetabular shell loosening could not be confirmed in this instance without further radiographs and patient information being provided.Corrective action, preventive action, and/or field action: -no corrective or preventive actions are considered necessary at this time.Ifu and/or surgical procedure reference: -ifu 5401000277 rev b.The instructions for use provided with the g7 bispherical acetabular shell provides the following guidance: warning and precautions: -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.Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear.Use clean gloves when handling implants.-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.-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.Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult.The patient is to be made aware and warned in advance of surgery of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits.Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site.Possible adverse effects: -loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.Risk assessment: -the event reports revision due to loosening.-risk management report documents the estimated residual risk associated with the reported event.-failure analysis report 570, rev 1 concludes: a g7 bispherical acetabular shell was revised after 1 year, 8 months and 21 days due to loosening and was returned to zimmer biomet for evaluation with the corresponding e1 liner.-visual examination of the explanted g7 bispherical acetabular shell suggested that some degree of bone integration had occurred before revision.The reported loosening could not be confirmed in this instance.Sub-optimal positioning may have contributed to the early failure of the g7 bispherical shell, however further radiographic and patient information is required in order to determine the root cause of the component failure.-this hazard (improper/inadequate fixation) has a maximum severity of 4 which is described in the severity table as: s-4 results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.-the outcome of the reported event (surgical intervention) is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to the event date, being (b)(6) 2019.- sales (nov 2016 to nov 2019) = (b)(4) units.- complaints search was conducted for events occurring between nov 2016 to nov 2019 for item 110017332.- 2 complaints were identified for this item number including (b)(4).- therefore, the calculated occurrence rate is (b)(4).- this is considered an acceptable occurrence rate as per the rmf which estimates an acceptable occurrence rate of 2 ((b)(4) is considered an occurrence score of 2 (rare): 0.01% - 0.1%).If further information regarding the root cause of the reported event are provided risk should be re-assessed.Conclusion: a g7 bispherical acetabular shell was revised after 1 year, 8 months and 21 days due to loosening and was returned to zimmer biomet for evaluation with the corresponding e1 liner.The relevant manufacturing history records indicate that the item was manufactured and sterilised in accordance with the applicable specifications.Visual examination of the explanted g7 bispherical acetabular shell suggested that some degree of bone integration had occurred before revision.The reported loosening could not be confirmed in this instance.Sub-optimal positioning may have contributed to the early failure of the g7 bispherical shell, however further radiographic and patient information is required in order to determine the root cause of the component failure.The mhr review indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of revision with the information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 BISPHERICAL SHELL 52E
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9369747
• MDR Text Key: 167819152
• Report Number: 3002806535-2019-00897
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110017332
• Device Lot Number: 6144757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention