MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS STEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN1102902

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

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/1901

Event Type  Injury  

Event Description

In a scientific publication, author: chen min, "direct anterior approach for total hip arthroplasty in the lateral decubitus position:early clinical results" it was reported that during surgery the proximal femoral bone fractured intraoperatively, this was treated with cerclage wires fixation and after this the femoral stem was impacted.There is not enough information to make a cross-check between the patients and the devices involved.The study involved 60 hips and 18 hips used reflection cups, 6 hips used sl-plus stems and 12 hips used synergy stems, the rest of the devices involved in the cases were from competitors.

Manufacturer Narrative

The study of chen min [1] reports surgeries on 60 hip, in 6 of which an sl-plus stem was used.For a sl stem, it was reported that the proximal femoral bone fractured intraoperatively.The complaint device, used in treatment, was not received for investigation, a visual inspection could not be performed.The part and the batch number of the device is not known.Therefore, the batch record review and a complaint history review could not be performed.The device labeling were reviewed, the ifu for the complaint device (lit.No.12.23, ed.05/16) stated bone fractures among possible side effects resulting from hip arthroplasty.The severity and the failure mode are covered through our risk management.No patient information nor any other medication documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode cannot be confirmed and the root cause of the problem stays undetermined due to insufficient information.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.[1]: chen, min; direct anterior approach for total hip arthroplasty in the lateral decubitus position: early clinical results; the journal of arthroplasty, volume 32, issue 1, 2017, pages 131-138, issn 0883-5403, https://doi.Org/10.1016/j.Arth.2016.05.066 sign-off date 5/13/2020.

• Brand Name: UNKN. SL-PLUS STEM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9772751
• MDR Text Key: 187013565
• Report Number: 9613369-2020-00037
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKN1102902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other