MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STEM LATERAL 5 NON-CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 11535

Device Problem Break (1069)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/20/2017

Event Type  Injury  

Event Description

User report (b)(4) reported through (b)(6): breakage of the stem at the cone 13 years after implantation right hip ((b)(6) 2004) and 2 preceding revision surgeries right hip ((b)(6) 2009 change of the acetabular shell /(b)(6) 2016 change of the acetabular shell and the ball head).The affected devices of the preceding revision surgeries are unknown.

Event Description

User report (b)(6) reported through (b)(6): breakage of the stem at the cone 13 years after implantation right hip ((b)(6) 2004) and 2 preceding revision surgeries right hip ((b)(6) 2009 change of the acetabular shell / (b)(6) 2016 change of the acetabular shell and the ball head).The affected devices of the preceding revision surgeries are unknown.Update 08.01.2018: device data and further information to the preceding revision surgery in (b)(6) 2016 received (filed under (b)(4), fda ref.9613369-2018-00004).Surgical history: (b)(6) 2016: revision right hip due to loosening of the bicon-plus shell with exchange of the shell, insert, ball head in (b)(6) ((b)(4), fda ref.9613369-2018-00004) (b)(6) 2009: revision right hip due too shell loosening with exchange of the shell and insert (affected devices unknown) in (b)(6).(b)(6) 2004: initial implantation right hip in (b)(6).(b)(6) 2004: initial implantation left hip in klinikum aue.

• Brand Name: SL-PLUS STEM LATERAL 5 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• MDR Report Key: 7062590
• MDR Text Key: 93029861
• Report Number: 9613369-2017-00066
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K021178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2011
• Device Model Number: 11535
• Device Catalogue Number: 75002757
• Device Lot Number: 0408.13.3596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 98