MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR LAT. TI/HA 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENT, METAL/POLY, NON-POROUS, CA-PHOSPH

Model Number 75018415

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to constant dislocations.The surgeon attempted to replace the liner and add 3 screws and a r3 liner to obtain stability but was not achieved.After this the cup was removed and also the stem.The final result was successful and the wound was closed.

Manufacturer Narrative

Additional information provided in: d10 (additional concomitant device was added) and ( health effect - impact code and component code) results of investigation: it was reported that the patient underwent revision surgery due to constant dislocations.A polarstem collar lat.Ti/ha 4 became loose during the case and was revised.The device, which intent use is in treatment, was not received for investigation.Furthermore no clinical documenation got available.A design history review was performed.No deviations could be found in the corresponding batch record review.For the specific batch number no other complaint was found.There is no indication that the device failed in any way.The root cause for this failure remains undetermined.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The current instruction for use for hip implants 12.23 ed.05/16 lists dislocation as a known possible side effect resulting from a hip arthroplasty.Internal complaint reference case-(b)(4).

• Brand Name: POLARSTEM COLLAR LAT. TI/HA 4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENT, METAL/POLY, NON-POROUS, CA-PHOSPH
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10788682
• MDR Text Key: 214746417
• Report Number: 9613369-2020-00227
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07611996103526
• UDI-Public: 07611996103526
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 75018415
• Device Catalogue Number: 75018415
• Device Lot Number: B1925014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2020
• Patient Sequence Number: 1
• Treatment: HEAD 71343608, LOT 19MM12098; REF INTERFIT THRD HOLE COVER (71330001)
• Patient Outcome(s): Hospitalization; Required Intervention