MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)

Catalog Number UNKN1102901

Device Problem Loss of Osseointegration (2408)

Patient Problem Joint Laxity (4526)

Event Date 04/16/2021

Event Type  Injury  

Event Description

It was reported that on literature review ¿hip international - 2013 - the fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years¿.It was reported that the sl-plus stem was revised due to aseptic loosening 35 months after implantation.Primary surgery was performed due to primary oa.

Manufacturer Narrative

H3, h6: the study of garcía-rey e.[1] reports surgeries on 889 hips.In 330 cases a sl stem was implanted in combination with an ep-fit cup.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that in one case the patient suffered from an aseptic loosening 35 months after implantation.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 performed.The reported failure mode might occur in some cases, which is stated as a side effect.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]: garcía-rey e.The fate of sagittal alignment in tapered uncemented femoral components in total hip arthroplasty: 889 hips followed for a minimum of 10 years.Hip int.2020 jan 7:1120700019895983.Doi: 10.1177/1120700019895983.

• Brand Name: UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
• Type of Device: SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11794690
• MDR Text Key: 249664140
• Report Number: 9613369-2021-00194
• 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: 06/14/2021

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: UNKN1102901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention