MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACET LNR 28X46/48 20 DEG; PRSTHSS,HIP,HEMI, TRNNNBARING,FMRL,MTLPLYACETAL

Catalog Number 427482

Device Problem Connection Problem (2900)

Patient Problem Injury (2348)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, based on the available information, the root cause for the "loosening" or the "infection" cannot be concluded.Should any relevant clinical/medical information become available this complaint can be re-assessed.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: ACET LNR 28X46/48 20 DEG
• Type of Device: PRSTHSS,HIP,HEMI, TRNNNBARING,FMRL,MTLPLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN
• MDR Report Key: 7411524
• MDR Text Key: 104841987
• Report Number: 1020279-2018-00746
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 427482
• Device Lot Number: 3Y72779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• 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
• Patient Age: 58 YR