MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 51OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325051

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/31/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.Tandem head and inner head were exchanged.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A review of the complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our clinical/medical team concluded: clinically relevant supporting documentation was not provided; therefore a thorough medical investigation could not be performed.However, a dislocation was reportedly the cause for the revision although the root cause for the dislocation was not identified.The patient impact beyond the reported revision cannot be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the actual products involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 51OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8371590
• MDR Text Key: 137191090
• Report Number: 1020279-2019-00831
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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: Health Professional
• Device Catalogue Number: 71325051
• Device Lot Number: 09GM09424A
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention