MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN POLARSTEM HIP INSTR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Problem with Sterilization (1596)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tha surgery, the sterilization of the unknown polarstem hip instrument was poor.After a delay of 60 min, because of re-sterilization, surgery was resumed, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H6: it was reported that, during a tha surgery, the sterilization of the unknown polarstem hip instrument was poor.After a delay of 60 min, because of re-sterilization, surgery was resumed, with the same device.Patient was not harmed as consequence of this problem.The complaint device, used in treatment, was not returned hence the product evaluation could not be performed.The article number and lot number of this complaint device were not provided and remain unknown.A review of the risk management documentation and corrective actions could not be performed due to insufficient information.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.A relationship between the reported event and the device cannot be confirmed and the root cause of the reported issue remains undetermined.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

Manufacturer Narrative

H10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the procedure was completed without any delay.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, 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).

• Brand Name: UNKN POLARSTEM HIP INSTR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 12770795
• MDR Text Key: 280462120
• Report Number: 9613369-2021-00396
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2022

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 01/04/2022
• Supplement Dates FDA Received: 01/04/2022; 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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