MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR TI/HA); PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problem Confusion/ Disorientation (2553)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Cypres, a., fiquet, a., girardin, p., fitch, d., bauchu, p., bonnard, o., & roy, c.(2019).Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis.Journal of orthopaedic surgery and research, 14(1), 1-6.Doi: https://doi.Org/10.1186/s13018-019-1436-y.

Event Description

It was reported that on literature review "long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis", 1 patient suffered from delirium tremens after a primary thr with the polar system.It was not reported how the adverse event was resolved.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6: in the literature article of cypres et al.2019 [1], it was reported that, 1 patient suffered from delirium tremens after a primary total hip replacement surgery with the polar system.The device, used in treatment, was 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 device 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.A review of the device labelling revealed that the ifu (lit.No.12.23 ed.03/21) states known possible risk factors and side effects in combination with the implantation of a hip prosthesis.Based on the performed 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.

Manufacturer Narrative

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

• Brand Name: UNKN. POLARCUP SHELL NON-CEMENTED (TI-PLASMA OR 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: 14279669
• MDR Text Key: 290662227
• Report Number: 9613369-2022-00252
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• 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

• 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
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 07/13/2022
• Supplement Dates FDA Received: 06/21/2022; 07/19/2022
• 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