MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 43OD 26ID; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71325043

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

Patient Problem Joint Dislocation (2374)

Event Date 04/16/2018

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to frequent dislocation.The patient had acetabular dysplasia.The surgeon thought this revision was not a product failure.No more information is available.

Manufacturer Narrative

The associated tandem bp liner and oxinium femoral head were not returned for evaluation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The devices were manufactured in 2017. a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no sufficient relevant supporting documentation was provided to perform a thorough medical investigation.However, it was communicated that the surgeon did not fault the component, as the patient had frequent dislocations secondary to acetabular dysplasia, and no further information will be provided.Therefore, the frequent dislocations secondary to the acetabular dysplasia were the contributing factors to the reported revision.No further medical assessment can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 43OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7522486
• MDR Text Key: 108530415
• Report Number: 1020279-2018-00952
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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: 71325043
• Device Lot Number: 17LM00074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: 90 YR