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

Device Problem Defective Device (2588)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that defective hip implant resulted in personal injury.

Manufacturer Narrative

Upon review of further information it has been determined that this case is not reportable and should therefore be disregarded.Based on the information provided, the device did not cause or contribute to a death or serious injury, nor has it been implicated by the physician.In addition, the information provided does not reasonably suggest that the device malfunctioned.Therefore, under the regulations set forth under 21 cfr 803.50 (1) or (2), it is concluded that this is not a reportable event.

• Brand Name: ACETABLR CUP HAP
• 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
• MDR Report Key: 9504278
• MDR Text Key: 172288126
• Report Number: 3005975929-2019-00442
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention