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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 09/03/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed because the wearing of the junction between head and stem neck is needed to investigate.The revised devices are to be returned for evaluation.

Manufacturer Narrative

The associated synergy select ii cemented standard offset stem, tandem shell/liner bipolar, uni femoral cocr head and locking ring were returned and evaluated.A lab analysis conducted during this investigation noted the bi-polar/liner construct was returned assembled with internal polyethylene components, femoral head and stem fully locked in place.No visual damage was observed.Scratches on the neck of the stem, gouging and scratches on the femoral head were likely due to removal.The devices show the head is too large to pass through the opening of the bi-polar/liner construct.The head would need to pass through the opening in order to disassemble.This demonstrates that the head diameter was large enough to be constrained within the bi-polar component, as designed.Locking ring was disassembled from bi-polar/liner construct and both were examined.No visible deformation or damage on the construct and the ring.Scratches were visible on the lateral face of the locking ring, likely due to explant or disassembly, but no other damage was visible.Dimensional evaluation was performed on the lock ring.The thru hole, groove, and countersink diameters each measured over-sized.Deviations are likely a result of observed damage.Therefore, the failure mode cannot be confirmed through dimensional analysis.A clinical evaluation noted there is no report of the patient's current condition; therefore no further clinical assessment is warranted.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN 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: 7974728
• MDR Text Key: 124000039
• Report Number: 1020279-2018-02160
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention