MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Event Description

It was reported that mismatched devices were implanted.Revision surgery believed to have been performed or scheduled as a result.Further details are being sought and will be communicated via a follow up report.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR ACETABULAR CUP 50MM
• 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: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7111981
• MDR Text Key: 94623342
• Report Number: 3005975929-2017-00468
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 084654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, #(B)(4), LOT # NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR