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

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Internal reference number: case (b)(4).

Manufacturer Narrative

D4: lot number and expiration date added.H4: manufacture date added.Internal complaint reference: (b)(4).

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 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
• Type of Device: 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
• MDR Text Key: 288876725
• Report Number: 9613369-2022-00076
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556535578
• UDI-Public: 00885556535578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 03/16/2022; 05/17/2022
• Supplement Dates FDA Received: 04/19/2022; 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1