MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 05/22/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability.The liner and head were exchanged.In addition to this the patient had 2 dislocations in the past on (b)(6) 2017 and (b)(6) 2017.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that the patient¿s dislocation was caused by the patient¿s hyper flexion and not associated with a mal performance of the implant.It cannot be determined to what extent the patient¿s history of spinal fusion, smaller femoral head, and early dislocation had on her subsequent dislocation and need for revision.As well as the acetabular anteversion at 35 degrees.It should be noted that some patients can be genetically predisposed to heterotopic ossification.It is a known complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond revision and expected transient post op convalescence period cannot be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include patient¿s failure to follow precautions, device selection or ossification.

• Brand Name: HIP IMPLANT
• 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: 9520092
• MDR Text Key: 172722758
• Report Number: 1020279-2019-04597
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention