MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTED; 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 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Zha, x., cheng, w., lü, h., li, z., liu, w., qi, l., & jing, j.(2018).Early effects of direct anterior approach versus posterolateral approach in total hip arthroplasty.Chinese journal of tissue engineering research, 22(35), 5583.Doi: 10.3969/j.Issn.2095-4344.1003.

Event Description

It was reported that on literature review "early effects of direct anterior approach versus posterolateral approach in total hip arthroplasty", 3 patients suffered from an unspecified femur fracture after having a primary tha surgery, using the direct anterior approach.It is unknown how the fractures were treated, but all the patients got better.No further information is available.

Manufacturer Narrative

H3, h6: in the literature article of cheng et al.2018 [1], it was reported that, 3 patients suffered from an uspecified femur fracture after having a primary total hip arthroplastic surgery with an unknown polarstem cementless, using the direct anterior approach.The part and the batch number of the reported complaint are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.The reported failure mode 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).The severity and the failure mode are covered through our risk management.Based on the provided medical information, a conclusion from the medical investigation cannot be done due to limited information.Based on our investigations the failure mode and the relationship between the device and the reported event 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.[1]: cheng zha xiaowei [early effects of direct anterior approach versus posterolateral approach in total hip arthroplasty].Zhongguo zuzhi gongcheng yanjiu yulin chuang kangfu (= chinese journal of tissue engineering research), doi: 10.3969/j.Issn.2095-4344.1003.Internal complaint reference: (b)(4).

• Brand Name: UNKN. POLARSTEM CEMENTED
• 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: 14014170
• MDR Text Key: 288599037
• Report Number: 9613369-2022-00073
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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?: No
• Date Manufacturer Received: 04/25/2022
• 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): Other