MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 42OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325042

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 01/10/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to recurrent dislocation.

Manufacturer Narrative

The associated tandem bipolar shell and cobalt chrome femoral head were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should the devices or additional information be received, the complaint will be reopened.

Manufacturer Narrative

Correct event description added.

Event Description

It was reported that a revision surgery was performed due to recurrent dislocation.Primary surgery was performed on (b)(6) 2018 due to femoral neck fracture.After the primary surgery, posterior dislocation occurred twice on unknown dates, both were fixed by manual reduction.On (b)(6) 2019 a revision surgery was performed.The surgeon does not blame the product.

• Brand Name: TNDM BP SHL/XLPE LNR 42OD 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: 8307889
• MDR Text Key: 135091345
• Report Number: 1020279-2019-00400
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325042
• Device Lot Number: 18FM06896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention