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 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Hoskins, w., rainbird, s., peng, y., graves, s.E., & bingham, r.(2022).The effect of surgical approach and femoral prosthesis type on revision rates following total hip arthroplasty: an analysis of the most commonly utilized cementless stems.Jbjs, 104(1), 24-32.Doi: http://dx.Doi.Org/10.2106/jbjs.21.00487.

Event Description

It was reported that on literature review "the effect of surgical approach and femoral prosthesis type on revision rates following total hip arthroplasty", data was collected from the (b)(6) registry ((b)(6)) from 1-jan-2015 to 31-dec-2019.7972 primary tha surgeries with the polarstem component were evaluated according to implant survival rate.It was reported that total, 40 patients suffered from a fracture and needed a revision surgery.The outcome of the patients is unknown.No further information is available.

Manufacturer Narrative

H3, h6: in the literature article of hoskins et al.2022 [1], it was reported that 40 patients suffered from a facture and needed a revision surgery after a polarstem component was implanted.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 "hip 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.[1]: hoskins, wayne mbbs(hons), fracs, phd, rainbird, sophia phd; peng, yi med(epi&stats); graves, stephen e.Mbbs, dphil(oxon), fracs(orth), faortha and bingham, roger mbbs, fracs2; the effect of surgical approach and femoral prosthesis type on revision rates following total hip arthroplasty, the journal of bone and joint surgery: january 5, 2022 - volume 104 - issue 1 - p 24-32, doi: 10.2106/jbjs.21.00487.

• 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: 14269456
• MDR Text Key: 290784797
• Report Number: 9613369-2022-00232
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• 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: 06/07/2022
• 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
• Patient Outcome(s): Other; Hospitalization