MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 3 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75002699

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported a stem loosening after implantation.No more information was reported.

Manufacturer Narrative

Results of investigation: it was reported that an unknown sl plus stem was loosening after implantation.The device in question was not sent back for investigation and no batch number was communicated.An appropriate investigation could therefore not be conducted.The stated failure mode could not be confirmed and the root cause stays undetermined.Based on available information the need for corrective action is not indicated.The complaint will be reopened should additional information be received.Smith and nephew will continue to monitor this device for similar issues.

Event Description

It was reported that a patient had a fall and later x-ray showed a sintering of the stem.A revision surgery of the stem was performed due to loosening.

Manufacturer Narrative

Roi updated: this complaint from germany reports a loose hip stem that required a revision.The reported stem is a sl-plus standard stem size 3, which was used in treatment.The primary surgery was performed in (b)(6) 2018.The complaint was re-opened due to provided clinical documentation.Product or batch number are still missing.Thorough investigations could not be performed due to insufficient information.The examination of the clinical documentation was performed.The patients fall cannot be ruled out as a contributing factor to her subsided and loosened stem prosthesis.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported effusion cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Implant loosening is a known possible side effect and mentioned in the hip ifu 12.23.Should information become available, this complaint can be re-assessed.At that time of investigation the root cause remains undetermined.Smith + nephew will continue to monitor this device for similar issues.

Manufacturer Narrative

Updated results of investigation: this complaint from germany reports a loose hip stem that required a revision.The reported stem is a sl-plus standard stem size 3, which was used in treatment) and wasn't sent back for investigation.The primary surgery was performed in (b)(6) 2018.The complaint was re-opened due to provided clinical documentation.Batch number is still missing.Thorough investigations could not be performed due to insufficient information.One similar complaint have been identified for this part number in the last five years.This failure mode will continue to be monitored.No corrective action is deemed required at this moment.The examination of the clinical documentation was performed.The patients fall cannot be ruled out as a contributing factor to her subsided and loosened stem prosthesis.Without the supporting lab/pathology results and/or the analysis of the explanted components, the root cause of the reported effusion cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Implant loosening is a known possible side effect and mentioned in the hip ifu 12.23.Should information become available, this complaint can be re-assessed.At that time of investigation the root cause remains undetermined.

• Brand Name: SL-PLUS STANDARD STEM 3 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 8671400
• MDR Text Key: 147081370
• Report Number: 9613369-2019-00045
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K072852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75002699
• Device Lot Number: H1800901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR