MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKN1102901

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 01/01/1901

Event Type  Injury  

Event Description

On the literature article named "spinopelvic alignment does not change after bilateral total hip arthroplasty in patients with bilateral crowe type-iv developmental dysplasia of the hip", it was reported that a patient underwent a revision surgery of the sl-plus family stem due to instability, loosening and subsequent nonunion of the stem at the osteotomy site at the distant end of the trochanter minor.The outcome of the patient is unknown.

Manufacturer Narrative

The study of can a [1] reports surgeries on 27 patients.It was reported that one patient required revision surgery because of instability, loosening and subsequent nonunion of the stem at the osteotomy site at the distal end of the trochanter minor.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.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.The reported failure mode is stated as a side effect in the ifu lit.No.12.23 ed.05/16.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.[1]: can a, erdogan f, yontar ns, övül erdogan a, erdem mn, sarikaya ia.Spinopelvic alignment does not change after bilateral total hip arthroplasty in patients with bilateral crowe type-iv developmental dysplasia of the hip.Acta orthop traumatol turc 2020; 54(6): 583-6.

• Brand Name: UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11992833
• MDR Text Key: 256035139
• Report Number: 9613369-2021-00292
• Device Sequence Number: 1
• Product Code: KWY
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1102901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention