MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM IMPACTOR CURVED; PROST, HIP, S-CNSTRND, M/C/P, CMNTD OR NOPOR, UNCNTD

Model Number	75000675
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during total hip replacement, the tip of a polarstem stem impactor broke outside the patient.No pieces fell into patient.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Additional Manufacturer Narrative
D4: lot number and expiration date added.H4: manufacture date added.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: additional information received by the manufacturer identified that this event should be re-evaluated for mdr reporting.The new information received confirmed that the tip of the polarstem stem impactor curved is heavily deformed and that no piece is broken off.The reassessment determined that the issue does not meet the threshold for reporting and; therefore, it is a non-reportable event.If further details are provided, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference: (b)(4) corrected data: b5, g2, h6 (medical device problem code).
Event or Problem Description
It was reported that, during total hip replacement, the tip of a polarstem stem impactor curved got deformed.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.

• Brand Name: POLARSTEM STEM IMPACTOR CURVED
• Common Device Name: PROST, HIP, S-CNSTRND, M/C/P, CMNTD OR NOPOR, UNCNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14048319
• Report Number: 9613369-2022-00076
• Device Sequence Number: 6044039
• Product Code: LZO
• UDI-Device Identifier: 00885556535578
• UDI-Public: 00885556535578
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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: 75000675
• Device Catalogue Number: 75000675
• Device Lot Number: B68259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 05/17/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 04/19/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown