MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; PROSTHESIS,HIP,SEMICONSTRAINED,METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT

Model Number	75023745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem Description
It was reported that before a thr procedure the polarstem fin stabilizer for 21000300 was found broken.Surgeon changed the surgical technique due to this problem.
Additional Manufacturer Narrative
Results of investigation: it was reported that before a total hip replacement procedure, the polarstem fin stabilizer for 21000300 was found broken.No patient harm was reported.The impact cap and the threaded rod of the device (parts of the polarstem stem inserter, 75004650), used in treatment were returned for investigation.The rest of the device was not returned.Furthermore, the reported polarstem fin stabilizer for 21000300 was not returned for investigation.Upon visual inspection, the reported fracture failure mode could be confirmed.The pin of the threaded rod, originally pinned with the impact cap is broken.Apart from that, signs of impaction dells are visible on the impact cap.During surgery, the surgeon changed the surgical technique due to the occurred issue and a different polarstem instrument set was opened.No patient injury is being reported and therefore no further clinical assessment is warranted at this time.According to the document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition (lit.No.12.23 ed.05/16).The failure mode and the severity are covered in the concerning risk management file.No additional complaint was detected for the batch in question.The production documentation, was reviewed.There is no indication that the device did not meet the specifications at the time of manufacturing, which could have contributed to the reported device failure.The detected dells on the impact cap indicate that excessive impact loading or force was applied on the device.It is suggested that the instrument was improperly used to impact a stem.It is to be noted that the stem inserter is intended to be used for the insertion of cemented stems, while the stem impactor (75023369) is to be used for impaction of uncemented stems.The stem inserter is not designed to withstand malleting impacts.Based on the performed investigation, the root cause of the reported event is attributed to an off-label use.The relevant surgical technique, 01217-en (1513) v5 09/17, illustrates in details how uncemented stems are implanted and which instrument should be used.S+n will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: POLARSTEM STEM INSERTER
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11072108
• Report Number: 9613369-2020-00274
• Device Sequence Number: 11590828
• Product Code: LZO
• UDI-Device Identifier: 07611996114829
• UDI-Public: 07611996114829
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 75023745
• Device Catalogue Number: 75004650
• Device Lot Number: D54778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention