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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 02/08/2017

Event Type  Injury  

Event Description

A revision of the cup was reported due to luxation.

Manufacturer Narrative

Results: this is a complaint reporting two revisions of the same hip.The devices in question have not been returned for investigation and no product nor batch number was communicated.A review of the device documentation or evaluation of the products could not be performed.The first revision (smith and nephew reference (b)(4)) replaced the cup, one week post implantation, secondary to two dislocations.17 undated x-rays were sent for review with this complaint but do not give a reason for the two cup revisions.There is a radiolucent line seen around the cup but it is not known if this was the cup of the first or second revision.The second revision (smith and nephew reference (b)(4)) reported ¿a strong suspicion of aseptic cup loosening¿.The femoral head, liner and cup were replaced two years after the first revision.No medical documents were provided with the second revision.It was communicated no further information would be forthcoming.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Based on available information the failure mode could not be confirmed and the root cause stays undetermined.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The need for corrective action is not indicated.Nevertheless smith and nephew will continue to monitor the devices for similar issues.The complaint will be reopened should additional information be received.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8412964
• MDR Text Key: 138550649
• Report Number: 9613369-2019-00021
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• 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: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR