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

Model Number 75002699

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/16/2020

Event Type  Injury  

Event Description

It was reported that patient suffered the breakage of the sl-plus standard stem 3 non-cemented.Its is not known how long after primary procedure it happened.

Manufacturer Narrative

Results of investigation: it was reported that patient suffered the breakage of the sl-plus standard stem size 3 (75002699).Its is not known how long after primary procedure it happened.The device is question, used in treatment, was not received for evaluation.A production record review showed no deviations from standard procedures.There was no further complaint reported for the batch in question.The failure is covered through our risk management file.The ifu mentions breakage as a rare side effect.A medical assessment was not possible, as no medical documentation was provided.The surgeon reported that the breakage was very atypical.Without the part, a through investigation of this fracture is not possible.Should the devices or any other information become available, this complaint will be reassessed.To date, no further actions are deemed necessary.Smith and nephew will monitor this device for further similar issues.

• Brand Name: SL-PLUS STANDARD STEM 3 NON-CEMENTED
• Type of Device: PRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10261770
• MDR Text Key: 198495711
• Report Number: 9613369-2020-00140
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996078657
• UDI-Public: 07611996078657
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2016
• Device Model Number: 75002699
• Device Catalogue Number: 75002699
• Device Lot Number: F0911396
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention