MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/05/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed for failure of the left hip replacement due to metallosis, adverse tissue reaction.Elevated metal levels and fluid.

Manufacturer Narrative

Please void this report and reference (manufacturer report number 3005975929-2020-00189) for more details.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10067939
• MDR Text Key: 191392576
• Report Number: 3005975929-2020-00134
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP CUP; UNKN BIRMINGHAM HIP MODULAR HEAD SLEEVE; UNKN SYNERGY HIP STEM
• Patient Outcome(s): Hospitalization; Required Intervention