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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure and outside the patient the polarstem knock plate large broke while being malleted during surgery.No injuries or surgical delays reported.It is not known how this procedure was completed.
Additional Manufacturer Narrative
It was reported that during procedure and outside the patient the polarstem knock plate large (75102238) broke while being malleted during surgery.The device intended for use during treatment was not returned for investigation and no batch number was communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.The risk of the device is monitored throughout pms activities.Therefore, the need for corrective action is not indicated.Based on available information a root cause cannot be determined.Nevertheless, smith and nephew will continue to monitor the device for similar issues.The complaint will be reopened should the complained device or additional information be received.

• 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: 10646377
• Report Number: 9613369-2020-00202
• Device Sequence Number: 3605008
• Product Code: JDI
• UDI-Device Identifier: 00885556535417
• UDI-Public: 00885556535417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1