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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2020-00227
• Device Sequence Number: 19560282
• Product Code: MEH
• UDI-Device Identifier: 07611996103526
• UDI-Public: 07611996103526
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75018415
• Device Catalogue Number: 75018415
• Device Lot Number: B1925014
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEAD 71343608, LOT 19MM12098; REF INTERFIT THRD HOLE COVER (71330001)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention