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

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Willburger, r.E., heukamp, m., lindenlaub, p., efe, t., peterlein, c.D., & schüttler, k.F.(2020).Excellent midterm survival and functional outcomes of a fully hydroxyapatite-coated cementless stem: first results of a prospective multicenter study.Arthroplasty today, 6(2), 201-205.Doi: 10.1016/j.Artd.2020.01.009.

Event Description

It was reported that on literature review "excellent midterm survival and functional outcomes of a fully hydroxyapatite-coated cementless stem: first results of a prospective multicenter study", 1 patient had a fracture at the 3-year follow up.It is unknown how this event was treated.No further information is available.There is no information within the study to determine whether these adverse events occurred in (b)(6) or in (b)(6).

Manufacturer Narrative

H3, h6: in the literature article of willburger et al.2020 [1], it was reported that, 1 patient suffered from a fracture at 3-year follow-up after a primary total hip replacement surgery with the polar system.The devices, used in treatment, were not returned for investigation and the part and batch number of the reported complaint are not known.Therefore, it is not possible to investigate whether the reported devices met manufacturing specification upon release for distribution.The severity and the failure mode are covered through our risk management.A thorough medical investigation could not be performed due to insufficient information.The reported failure mode "fracture" is stated as a potential adverse device effect in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Based on the performed investigations, the failure mode and the relationship between the devices and the reported events cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event and it is not possible to perform a review of past corrective actions.No probable cause can be determined and no further actions will be taken to this date.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.

Manufacturer Narrative

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

• Brand Name: UNKN. POLARSTEM CEMENTLESS (TI/HA)
• 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: 14279472
• MDR Text Key: 290660649
• Report Number: 9613369-2022-00239
• Device Sequence Number: 1
• Product Code: JDG
• 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,Literature,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Other