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

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

Patient Problems Ossification (1428); Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

Scientific publication, author: xu le, "the mid-term results of ceramic to ceramic coupled cementless total hip arthroplasty".It was reported that in 25 hips there was heterotopic ossification.There was observation and surgical excision for 1 case.In this paper 64 hips were discussed involving sl-plus.

Manufacturer Narrative

The study of xu qin [1] reports 25 cases of heterotopic ossification.In this paper, 64 hips were discussed involving sl-plus stems.An unspecified post-operative condition was reported for sl-plus stems; one stem required surgical incision and the second complaint was reported for 24 cases which did not require surgical intervention.The part and the batch number of these devices are not known.Therefore, the batch record review and complaint history review could not be performed for the complaint devices.The device labeling were reviewed, the ifu for the complaint devices (lit.No.12.23, ed.05/16) stated possible side effects among common adverse events resulting from hip arthroplasty.The severity and the failure mode are covered through our risk management.As the complaint devices were not returned for investigation, a visual inspection could not be performed.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 for the complaint devices 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]: xu qin; the mid-term results of ceramic to ceramic coupled cementless total hip arthroplasty; zhanjun orthopedics clinical master march 20, 2013 master thesis southern medical university guangzhou.

• 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: 9774165
• MDR Text Key: 187009922
• Report Number: 9613369-2020-00048
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention