MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL STD STEM 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED, UNCEMENTED

Catalog Number	75002697
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of the plus sl std stem 2 was performed due to right hip arthroplasty periprosthesis fracture, confirmed under x-rays.
Additional Manufacturer Narrative
The sl plus standard stem size 2 (75002697) was not received for investigation.It has been reported that a revision was preformed due to a periprosthetic fracture, from which the patient suffered after a fall.This was confirmed under x-ray.However the medical documentation was not available for the investigation of this complaint.There is no indication that the implant did not match specification at the time of manufacturing.There were no similar complaints reported for the batch in scope.If more information becomes available this complaint will be reopened.Smith + nephew will monitor this device for further similar issues.

• Brand Name: PLUS SL STD STEM 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhafstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8956956
• Report Number: 9613369-2019-00065
• Device Sequence Number: 16774474
• Product Code: LZO
• UDI-Device Identifier: 07611996078640
• UDI-Public: 07611996078640
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2021
• Device Catalogue Number: 75002697
• Device Lot Number: G1416634
• Initial Date Received by Manufacturer: 04/20/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 08/26/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/09/2019; 11/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR