MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTLESS (TI/HA); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, 4-5 years after a thr, the patient had a bad fall from her bed resulting in a periprosthetic fracture.On (b)(6) 2022 patient underwent a revision surgery to address the fracture by revising an uncemented polarstem and a 32mm oxinium femoral head.The procedure went without incident.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that, 4-5 years after a thr, the patient had a bad fall from her bed resulting in a periprosthetic fracture.On (b)(6)2022 patient underwent a revision surgery to address the fracture by revising an uncemented polarstem and a 32mm oxinium femoral head.The procedure went without incident.Current health status of the patient is unknown.The device in scope of this complaint, was not returned for investigation.A review of the complaint history was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.A review of the risk management documentation verified the failure mode and severity of the reported issue.The device labeling was reviewed, the ifu for the complaint device (lit.No.12.23, ed.03/21) stated possible side effect such as hip fracture resulting from hip arthroplasty.Due to insufficient information, it is not possible to perform a review of past corrective actions.For the medical investigation, the periprosthetic fracture and subsequent revision were reported as a result of the patients¿ ¿bad fall from bed¿ and is not associated with a mal performance of the implant.It should be noted the patients¿ osteoporosis cannot be ruled out as a contributing factor to the reported periprosthetic fracture.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.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.Should additional information become available, this complaint will be reopened.

• Brand Name: UNKN. POLARSTEM CEMENTLESS (TI/HA)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 15088478
• MDR Text Key: 296466610
• Report Number: 9613369-2022-00421
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 08/19/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNKN FEM HEAD MEMPHIS OX
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 68 KG