MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT WITH TI/HA 4 NON-CEM; PROSTHESIS,HIP,HEMI-,FEMORAL,METAL/POLY,CEMENTED-UNCEMENT

Catalog Number 75002081

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 05/01/2009

Event Type  Injury  

Event Description

It was reported that, 3 months after the patient underwent a primary left hip replacement on (b)(6) 2009 due to hip arthritis, the patient suffered from a lung embolism.The adverse event was determined as related to the procedure.It is unknown if/how this adverse event was treated.The outcome of the patient was not reported.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

D4: expiration date added.Case: (b)(4).D1: brand name updated.D4: catalog number and lot number updated.

Manufacturer Narrative

(b)(4).D1: brand name changed back to unknown part name.Previous part reported in error.D4: updated catalog number and lot number back to unknown.

Event Description

Study: polarstem cementless observational (b)(4); subject: (b)(4); ae: postoperative lung embolism.It was reported that, 3 months after the patient underwent a primary left hip replacement on (b)(6) 2009 due to hip arthritis, the patient suffered from a lung embolism.The outcome of the patient is presumed as resolved in 2009.Patient is currently in a reduced physical state due to a malignant disease.

Manufacturer Narrative

Additional info from sections b, d, and h has been already provided under report 9613369-2021-00430-3 amending info from section g and results of investigation.Results of investigation: it was reported that, 3 months after the patient underwent a primary left hip replacement on (b)(6) 2009 due to hip arthritis, the patient suffered from a lung embolism.The adverse event was determined as related to the procedure.The polarstem intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.A review of the complaint history revealed no additional complaint for the batch in question.The failure mode, severity and occurrence stated in the corresponding risk file are adequate.Due to insufficient information it is not possible to perform a review of past corrective actions.Review of past corrective actions was performed.No further escalation is required.The instructions for use, lists embolism as known possible adverse effect resulting from a hip arthroplasty.A medical investigation was conducted.The occurrence of a lung embolism is a known complication of any surgery and is not presumed to be related to the implant.The reports were reviewed and provided insight into the reported issue.Based on the information provided, this adverse event was reported as resolved in 2009; therefore, no further clinical/medical assessment is warranted at this time.Based on the information provided, the reported failure mode cannot be confirmed.A relationship between the reported event and the device cannot be confirmed.The complaint description does not indicate a problem with the polarstem in scope.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.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.

• Brand Name: POLARSTEM STEM LAT WITH TI/HA 4 NON-CEM
• Type of Device: PROSTHESIS,HIP,HEMI-,FEMORAL,METAL/POLY,CEMENTED-UNCEMENT
• 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: 13087871
• MDR Text Key: 282777362
• Report Number: 9613369-2021-00430
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2012
• Device Catalogue Number: 75002081
• Device Lot Number: J380M10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 75003905,EP-FIT SHELL,C0815494; 75004007,EP-FIT REXPOL INSERT,B0814734; 75004172,CERAMIC BALL HEAD,B0810820
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 124 KG