MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE HA CTD ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331950

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 08/18/2017

Event Type  Injury  

Event Description

It was reported the surgeon said he felt the position of the acetabular component had too little anteversion and to much inclination.Preop ct assessment measured the primary positioning at around 50 degrees of inclination and 12 degrees of anteversion.This position coupled with her short large thighs made it possible for her to lever the femoral head out of the liner resulting in posterior dislocation.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A clinical investigation concluded that this complaint from (b)(6) reported a revision of a hip, 3 years post primary surgery, secondary to dislocations.It has been communicated that ¿the surgeon does not fault the implants¿.Based on the surgeons statement, the cause of the dislocations, that precipitated the revision, is the ¿too little anteversion and too much inclination¿ and not a product failure.No information on the patient¿s current status has been submitted to be included in a clinical investigation.A review of the manufacturing records did not reveal any material or manufacturing deviations that could have caused or contributed to the reported incident.A review of complaint history on the reportedly failed parts did not reveal any prior complaints for the listed batches.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.If the devices or new information are received in the future, this complaint can be re-opened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported a revision surgery was performed due to the femoral implant head causing posterior dislocation.

• Brand Name: R3 3 HOLE HA CTD ACET SHELL 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: markus poektter ; smith & nephew, inc.; memphis, TN 38116
• MDR Report Key: 6863076
• MDR Text Key: 86068082
• Report Number: 1020279-2017-00742
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070756
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Catalogue Number: 71331950
• Device Lot Number: 14BM02051A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2014
• 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 Weight: 100