MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 52OD 22ID; PROSTHESIS,HIP,HEMI,FEMORAL, METAL/POLYMER,CEMENTEDORUNCEMENTED

Catalog Number 71323052

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 08/06/2019

Event Type  Injury  

Event Description

It was reported that a revision was performed due to severe pain and fracture.Dr states that this revision was not caused by device but patient fell down.

Manufacturer Narrative

The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that several attempts have been made to obtain clinical/medical documents.It has been communicated that no information would be coming.Also communicated is that the doctor stated ¿this revision was not caused by device but patient fell down.¿ without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: TNDM BP SHL/XLPE LNR 52OD 22ID
• Type of Device: PROSTHESIS,HIP,HEMI,FEMORAL, METAL/POLYMER,CEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8994785
• MDR Text Key: 157468267
• Report Number: 1020279-2019-03330
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71323052
• Device Lot Number: 17DM04295
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention