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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Pleural Effusion (2010); Swelling (2091)

Event Date 07/02/2018

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to pain, elevated test results, large effusion and cystic pseudotumor that was resected.

Manufacturer Narrative

It has been determined that this submission is a duplicate of prior mdr 3005975929-2019-00083.Case investigation outcomes will be communicated via that report.Please disregard this mdr.

• Brand Name: ACETABLR CUP
• 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: sarah freestone
• MDR Report Key: 9558624
• MDR Text Key: 173954537
• Report Number: 3005975929-2020-00008
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention