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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 02/02/2007

Event Type  Injury  

Event Description

It was reported high levels of cocr in right hip.Bilateral patient.No revision done due to the age.

Manufacturer Narrative

This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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
• MDR Report Key: 9955770
• MDR Text Key: 187508917
• Report Number: 3005975929-2020-00112
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention