MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335754

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 07/08/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to recurrent dislocations.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.The lab analysis for the femoral, right tibial articulating insert, and left tibial articulating insert scratches on the femoral condyle articular surfaces that are along the radius are likely the result of articulation of the knee.The source of other scratches could not be determined from the information provided.No material or manufacturing deviations were observed in the course of this investigation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.The clinical/medical team concluded, it was communicated that clinically relevant documentation would not be available for inclusion in a medical assessment.It was reported that a previous spinal fusion was believed to possibly have contributed to the dislocation and subsequent revision.Based on the lab analysis, the explanted liner identified ¿deformation¿ which ¿is a consistent finding when there is impingement with the femoral component neck.The visual evidence of neck impingement suggest an alignment issue may have been one contributing to the cause for recurring dislocations¿.No further clinically relevant information was provided for inclusion in the medical investigation.The patient impact beyond the reported recurrent dislocations and subsequent revision could not be determined.No further medical assessment can be rendered at this time.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.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8830822
• MDR Text Key: 152325847
• Report Number: 1020279-2019-02776
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: 71335754
• Device Lot Number: 12AM07685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR