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

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 11/28/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability.Smith and nephew implants 62 shell, 40 liner, 40 ceramic oxinium head and size 4 high offset smf stem were removed and replaced with depuy pinnacle 64mm acetabular cup, 6.5mmx45mm cancellous bone screws, pinnacle altrx polyethylene acetabular liner +4 lateralized 10- degree angled, depuy corail revision femoral stem, size 15/high offset, biolox delta ceramic femoral head +12x36mm.

Manufacturer Narrative

The associated complaint devices were not returned.The medical investigation concluded that all documents and images provided as of this date have been reviewed and consider and unless noted do not contribute to the clinical investigation.The impact to this patient has been multiple interventions and surgeries with debility and recovery pain.The clinical information provided, of the ¿osteolytic/metallosis and synovial reaction¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause of the dislocations cannot be concluded based on the information provided.Without the actual product involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints 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: 8864340
• MDR Text Key: 153379841
• Report Number: 1020279-2019-02927
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention