MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Swelling (2091); Toxicity (2333)

Event Date 04/20/2013

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis due to loosening, pseudotumour and elevated levels of cobalt and chromium.

Manufacturer Narrative

(b)(4).

• Brand Name: ACETLR CUP HAP 50MM 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 5001 ; SZ 5001
• MDR Report Key: 6867819
• MDR Text Key: 86246145
• Report Number: 3005975929-2017-00278
• 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: 06/25/2018

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
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 081413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 09/12/2017; 09/12/2017
• Supplement Dates FDA Received: 11/28/2017; 06/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2007
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR