MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM KNOCK PLATE LARGE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75102238
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a thr surgery, the polarstem knock plate large popped off the broach handle.The procedure was finished without delays and with a smith and nephew back up device.No patient was harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery, the polarstem knock plate large popped off the broach handle.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.No additional complaint with batch a57730 was reported so far.As the part was not returned for investigation, the reported failure mode could not be confirmed and a relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the conducted investigation, the root cause could not be determined conclusively and the need for corrective actions is not indicated.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).Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemend necessary at the time.Smith+nephew will continue to monitor for similar issues.

• Brand Name: POLARSTEM KNOCK PLATE LARGE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11817229
• Report Number: 9613369-2021-00211
• Device Sequence Number: 3747563
• Product Code: JDI
• UDI-Device Identifier: 00885556535417
• UDI-Public: 00885556535417
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75102238
• Device Catalogue Number: 75102238
• Device Lot Number: A57730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1