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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 02/25/2019

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for having continued right hip dislocation with pain; the right hip cup was revised as a result.Surgical intervention was required to prevent permanent impairment to subject's body structure/function.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and based on the information provided root cause of the multiple dislocations and ongoing pain was due to impingement of the femoral neck and acetabular shell/liner which was lipped and had a large dent in the lip.The surgeon stated ¿this was likely from neck impingement.¿ the future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 8444911
• MDR Text Key: 139594459
• Report Number: 1020279-2019-01151
• 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
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 95