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

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.

• Brand Name: MLRY-HD 3HOLE RLC SHL 54MM/L24
• Type of Device: HIP 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 Key: 8273199
• MDR Text Key: 133943991
• Report Number: 3002806535-2019-00073
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K861114
• Number of Events Reported: 1
• 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 Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 11-104154
• Device Lot Number: 6096458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 01/24/2019 Patient Sequence Number: 1