MAUDE Adverse Event Report: SMITH & NEPHEW BHR; ACETABULAR CUP

Catalog Number 74120154

Device Problem Device Slipped (1584)

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

Event Date 05/08/2014

Event Type  Injury  

Event Description

It was reported that a second revision surgery of the right hip was performed due to subluxation, swelling, lumps in the groin area, pain in the buttocks and evidence of a soft tissue reaction.The acetabular cup was implanted (b)(6) 2010; the other devices were implanted during revision of the original femoral component on (b)(6) 2010, reported via mdr 3005477969-2015-00012.

Manufacturer Narrative

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; 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: terry mcmahon ; 970 lake carillon drive; st. petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4430011
• MDR Text Key: 15820959
• Report Number: 3005477969-2015-00013
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

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 Catalogue Number: 74120154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2015
• 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
• Treatment: MODULAR SLEEVE, # (B)(4) , LOT # 08LW19884; FEMORAL STEM, # (B)(4) , LOT # 02FM09453