MAUDE Adverse Event Report: BIOMET UK LTD. G7 BISPHERICAL SHELL 54F; ACETABULAR SHELL

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial and final report.Foreign report source: (b)(6).Occupation: post market surveillance senior specialist.Concomitant medical products: medical product: gts standard fmrl stem size +3, catalog #: ps129gp3, lot #: 1262071.Response received stating no further information available for siris outlier cases.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A complaint history search identified 4 complaints for similar harms for the same item number for the 3 years prior to the notification date (b)(6) 2017 to (b)(6) 2020), including (b)(4).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: this event reports a harm of loosening, which resulted in surgical intervention (revision surgery).The root cause of the harm could not be determined with the information currently available, therefore a specific hazard (line) within the risk table cannot be selected.Multiple lines cover a hazardous situation of inadequate fixation and a harm of loosening.These lines have a maximum severity of 4 (necessitates surgical intervention), and a maximum occurrence of 3 (1 in 100 to 1 in 1000).Severity assessment: the event reports that surgical intervention was required.This gives a severity of 4 (necessitates surgical intervention) and is in line with the risk file.Occurrence assessment: the sales data for item number 110017333 for the 3 years prior to the notification date of the reported event (b)(6) 2017 to (b)(6) 2020 (most up to date sales data available)) was found to be 1869 units.A complaint history search identified 4 complaints for similar harms for the same item number for the 3 years prior to the notification date (b)(6) 2017 to (b)(6) 2020), including (b)(4).The root cause of the 4 identified complaints has not be determined.As a hazard (single line) cannot be selected, any occurrence score calculated cannot be used for comparison.Therefore, an occurrence score has not been calculated on this occasion.If further information regarding the root cause of the reported event or reason for revision are provided, the risk will be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported the patient underwent a primary procedure.Subsequently, that patient underwent a revision procedure on due to acetabular loosening where the acetabular components and femoral components were removed.

• Brand Name: G7 BISPHERICAL SHELL 54F
• Type of Device: ACETABULAR SHELL
• 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: 10458977
• MDR Text Key: 204530697
• Report Number: 3002806535-2020-00383
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2020

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 Model Number: N/A
• Device Catalogue Number: 110017333
• Device Lot Number: 6126810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention