MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. MODULAR-PLUS REVISION STEM (UNKN. MODULE)

Catalog Number UNKN1101701

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

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 05/02/2018

Event Type  Injury  

Event Description

On the literature article named "outcomes of vancouver b2 and b3 periprosthetic femoral fractures after total hip arthroplasty in elderly patients", it was reported that, after a modular tapered rectangular titanium stem (modular plus) had been implanted on 1 patient, the patient had a dislocation.The patient required surgical intervention with resection arthroplasty to treat the adverse event due to an unspecified health-related condition.The patient outcome is unknown.

Manufacturer Narrative

Reports a retrospective follow-up study on 91 postoperative periprosthetic femoral fractures cases.A modular-plus stem was implanted in 24 patients.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It was reported that, after a modular tapered rectangular titanium stem (modular plus) had been implanted on 1 patient, the patient had a dislocation.The patient required surgical intervention with resection arthroplasty to treat the adverse event due to an unspecified health-related condition.The patient outcome is unknown.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.The reported failure mode might occur in some cases, which is stated as a side effect in the ifu lit.No.(b)(4).The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.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.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.(b)(6).

• Brand Name: UNKN. MODULAR-PLUS REVISION STEM (UNKN. MODULE)
• Type of Device: UNKN. MODULAR-PLUS REVISION STEM (UNKN. MODULE)
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11921870
• MDR Text Key: 253976058
• Report Number: 9613369-2021-00275
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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: UNKN1101701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention