MAUDE Adverse Event Report: BIOMET UK LTD. UNK ACETABULAR SYSTEM; HIP PROTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Initial report customer has indicated that a revision procedure is scheduled for a poly exchange, therefore, currently the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported that a patient underwent an initial hip arthroplasty prior to 2000.Subsequently, a revision procedure is scheduled for a poly exchange.

Event Description

It was reported that a patient underwent an initial hip arthroplasty prior to 2000.Subsequently, a revision procedure was performed on (b)(6) 2020 for a poly exchange.

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.Revision surgery took place on the (b)(6) 2020.Reason for the revision: poly exchange.Attempts were made to obtain additional information; however, none was available.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 item number and lot number is unknown.Complaint history search could not be performed as item number and lot number is unknown.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.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: UNK ACETABULAR SYSTEM
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11071162
• MDR Text Key: 223605867
• Report Number: 3002806535-2020-00558
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• 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: UNK ACETABULAR SYSTEM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other