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

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 05/01/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis and pseudotumor.

Manufacturer Narrative

It has been established that this incident represents a duplicate of the previously submitted mdr 3005975929-2018-00059.Therefore please disregard this report.

• Brand Name: BHR ACETABLR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone ; UK
• MDR Report Key: 7593440
• MDR Text Key: 110813285
• Report Number: 3005975929-2018-00195
• 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: health professional,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention