MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP 44MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122152

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problem Toxicity (2333)

Event Type  Injury  

Event Description

Patient reported problems with his hip implants (bhr) and elevated test results for cobalt and chromium in the blood.In addition, a squeaking and cracking was developed rather felt than heard.A revision surgery is planned in (b)(6) 2015.Patient suspects that the implants were not implanted in optimal position.Implantation was performed in (b)(6) 2012.

Manufacturer Narrative

• Brand Name: BHR ACETABULAR CUP HAP 44MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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; st petersburg, FL 33716 ; 0628320660
• MDR Report Key: 4873824
• MDR Text Key: 6058604
• Report Number: 3005477969-2015-00185
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2013
• Device Model Number: 74122152
• Device Catalogue Number: 74122152
• Device Lot Number: 08HW18303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2015
• Date Device Manufactured: 08/31/2008
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 60