• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET UK LTD. UNK ACETABULAR SYSTEM HIP PROTHESIS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK ACETABULAR SYSTEM
Type of DeviceHIP PROTHESIS
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 Key11071162
MDR Text Key223605867
Report Number3002806535-2020-00558
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Received12/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNK ACETABULAR SYSTEM
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/24/2020 Patient Sequence Number: 1
-
-