MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC

Catalog Number 74122160

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

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

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Left hip revision surgery was performed due to pain and elevated metal ion levels and multiple other systemic symptoms, including squeaking and grinding.

Manufacturer Narrative

[(b)(4)].

• Brand Name: BHR ACETABULAR CUP 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFAC
• 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
• MDR Report Key: 5390879
• MDR Text Key: 36851399
• Report Number: 3005477969-2016-00028
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Catalogue Number: 74122160
• Device Lot Number: 08HW18643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided; 01/13/2016
• Supplement Dates FDA Received: 05/05/2016; 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2008
• 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 Age: 61 YR