MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETLR CUP HAP 58MM W/ IMPTR

Model Number 74120158

Device Problem Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 10/02/2014

Event Type  Injury  

Event Description

A revision has been reported due to incompatible metal wear.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR
• Type of Device: ACETLR CUP HAP 58MM W/ IMPTR
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora, spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; baar; st petersburg, FL 33716 ; 0628320660
• MDR Report Key: 4195437
• MDR Text Key: 4968079
• Report Number: 3005477969-2014-00542
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 74120158
• Device Catalogue Number: 4120158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 62