MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120148

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Reaction (2414)

Event Date 10/05/2015

Event Type  Injury  

Event Description

Revision of a bhr due to loosening and metallosis 8 years and 8 months post-operative.The patient was provided with a bhr prosthesis (left) in (b)(6) 2007.In (b)(6) 2014, a blood analysis revealed increased results of cobalt and chrome, a further blood analysis in (b)(6) 2015 revealed continued increased results of cobalt and chrome, but the patient developed no symptoms until then.As from (b)(6) 2015, the patient felt pain in the area of the left hip, a mri on (b)(6) 2015 showed a pseudotumor as reaction to metal wear, x-rays showed loosening of the prosthesis.

• Brand Name: BHR ACETABULAR CUP 48MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK 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 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5645882
• MDR Text Key: 44889436
• Report Number: 3005477969-2016-00108
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2017

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: 10/31/2011
• Device Model Number: 74120148
• Device Catalogue Number: 74120148
• Device Lot Number: 67797 019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/15/2016; 02/21/2017; 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2006
• 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: 61 YR
• Patient Weight: 67