MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Toxicity (2333)

Event Date 06/07/2017

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to intra-articular synovitis.Presented with elevated cobalt and chromium levels, had pain in the hips and mri suggests pseudotumor formation.

Manufacturer Narrative

[(b)(4)].

• Brand Name: ACETLR CUP HAP 56MM W/ IMPTR
• 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 05001 ; SZ 05001
• MDR Report Key: 7154495
• MDR Text Key: 96045729
• Report Number: 3005975929-2017-00478
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Catalogue Number: 74120156
• Device Lot Number: 12JW09263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2017
• Date Device Manufactured: 11/21/2012
• 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: RESURFACING FEMORAL HEAD 50MM, 74121150/13AW09612
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR