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

Catalog Number 74122150

Device Problems Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 05/12/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to metallosis and elevated metal ion levels.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Revised due to failed left total hip arthroplasty secondary to bearing surface wear and periacetabular osteolysis.

• 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: 6841657
• MDR Text Key: 84645155
• Report Number: 3005975929-2017-00256
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

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: 04/30/2014
• Device Catalogue Number: 74122150
• Device Lot Number: 09DW23030 035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 08/28/2017; 08/28/2017
• Supplement Dates FDA Received: 10/19/2017; 05/11/2018
• Date Device Manufactured: 05/20/2009
• 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: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Age: 69 YR