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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. MLRY-HD 3HOLE RLC SHL 54MM/L24 HIP PROSTHESIS

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BIOMET UK LTD. MLRY-HD 3HOLE RLC SHL 54MM/L24 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Fitting Problem (2183); Activation, Positioning or SeparationProblem (2906); Positioning Problem (3009)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 12/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
During the thr procedure, upon insertion of acetabular components, the surgeon could not lock the liner into the 54 mm shell. After several attempts, the surgeon decided to replace this component with 56 mm shell. This caused 35 minutes delay in the procedure.
 
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Brand NameMLRY-HD 3HOLE RLC SHL 54MM/L24
Type of DeviceHIP PROSTHESIS
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 Key8273199
MDR Text Key133943991
Report Number3002806535-2019-00073
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K861114
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number11-104154
Device Lot Number6096458
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2017
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: 01/24/2019 Patient Sequence Number: 1
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