MAUDE Adverse Event Report: BIOMET UK LTD. EXCEED ABT 3HL SHELL 39/50MM; ACETABULAR SHELL

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in (b)(6).The customer reported that a revision surgery due to hip dislocation is planned, however, the revision has yet to be performed.The device remains implanted.Concomitant medical products: item: 650-0791, lot: unknown, item name: biolox delta lnr 32mm 50-52mm.This device is not cleared for distribution in the us and zb does not market or manufacture a similar device in the us.Therefore, an mdr will not be submitted for this device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

It was reported that the patient underwent initial surgery on unknown date (surgeon states it happened approximately 8 years ago).Subsequently, a revision surgery due to hip dislocation is planned (revision has yet to be performed).According to the surgeon the insert is dislocated in the shell.The date of the planned revision is unknown.Details of the initial surgery unknown.No information if the explants will be returned.

Event Description

It was reported that the patient underwent initial surgery on unknown date (surgeon states it happened approximately 8 years ago).Subsequently, a revision surgery due to hip dislocation is planned (revision has yet to be performed).According to the surgeon the insert is dislocated in the shell.Revision has yet to be performed (unknown date).Details of the initial surgery unknown.

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 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 could not be performed as lot numbers are unknown.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 650-0791 and item 123950.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports a harm of dislocation with a planned revision (no revision has taken place at the time the complaint was reported).The highest severity score associated with this failure mode is 4 (results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention).The event reported that surgical intervention is planned.This gives a severity score of 4, which does not exceed the severity score on the relevant line in the risk management file.No occurrence rate is required as the root cause of the dislocation has not been established, and no similar events have occurred for the same item number in the last 3 years.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.

• Brand Name: EXCEED ABT 3HL SHELL 39/50MM
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11018532
• MDR Text Key: 223442628
• Report Number: 3002806535-2020-00540
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 123950
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other