MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS BHR ACETLR CUP HAP 56MM W/IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, M

Model Number 74120156

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333)

Event Date 01/19/2015

Event Type  Injury  

Event Description

Patient submitted (b)(4).Left hip mom resurfacing performed 2007.According to the operative report, s and n 56mm cup and 50mm head implanted.Hip has become increasingly painful, with popping, clicking and squeaking.Pain and noises are worsening.In 2014 consulted with another surgeon.X-rays showed deterioration of the joint.Blood test for cobalt and chromium levels were "off the charts".Surgeon recommended revision to occur in 2015.

Manufacturer Narrative

[(b)(4)].

Event Description

It was reported that revision surgery was performed due to pain, metallosis and elevated cobalt and chromium levels.

• Brand Name: BHR ACETLR CUP HAP 56MM W/IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, M
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS ; auroa house, spa park; leamington spa CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau, FL 5001 ; SZ 5001
• MDR Report Key: 5004295
• MDR Text Key: 23150188
• Report Number: 3005477969-2015-00212
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Not Applicable
• Type of Report: Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: 74120156
• Device Catalogue Number: 74120156
• Device Lot Number: 076133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2007
• 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: 62 YR