MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 7 NON-CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 75002706

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 11/20/2017

Event Type  Injury  

Event Description

A revision surgery was reported due to pain.Stem was found loose.

Manufacturer Narrative

Results of investigation: a revision surgery of a sl-plus standard stem was reported.The stem was reported to have been found loose during the revision surgery.No part was returned for investigation.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No similar complaint was reported for this batch of devices.According to the provided implant report, the cup was placed in 35° inclination and the stem was in slight varus position.It is suggested that the acetabular cup is implanted in 45° inclination (surgical technique us, 2006).According to the provided revision report, the patient is morbid obese, had persistent pain and problems with the hip and mildly elevated serum cobalt and chromium levels.Further details about these values were provided.During the revision, evidence of adverse local tissue reaction with mild intra-articular necrosis and mild trunnion corrosion was noted.A synovial fluid aspirate and pathology was negative for periprosthetic joint infection and acute inflammation.The cup was reported to be well fixed and positioned but the stem was loose (aseptic loosening).No x-rays were provided to assess the reported implant position independently and to determine the onset of loosening respectively the post-implantation situation.The nature and reasons for the aseptic loosening remain unclear.Without the device available for analysis, no specific root cause for the reported issue can be determined.There is however to the best of our knowledge no indication that the reported stem failed to meet specifications at the time of manufacturing.No further actions have been initiated.If the explants or additional information becomes available in the future this investigation will be reopened.

• Brand Name: SL-PLUS STANDARD STEM 7 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: 8072234
• MDR Text Key: 127200260
• Report Number: 9613369-2018-00081
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K001942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2015
• Device Catalogue Number: 75002706
• Device Lot Number: E0806063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR