MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STEM LATERAL 4 NON-CEMENTED; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75002756
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to mobilization of the stem and wear of the polyethylene.
Additional Manufacturer Narrative
Results of investigation: it was reported that a revision surgery was performed due to mobilization of the sl-plus stem and wear of the bicon-plus pe insert.As of today, no device has been returned for investigation.An appropriate evaluation of the complained devices could therefore not be conducted.No medical records have been provided.The reported event could not be assessed and a thorough medical assessment could not be performed.A review of the batch record revealed no deviation from the standard manufacturing process for both devices in scope.The devices have been manufactured in 2006.A review of the complaint history revealed one other complaint for the batch of the sl-plus stem.No other complaint has been reported for the batch of the bicon-plus pe insert.The ifu (li.No.12.23 ed 05/16) states "wear and loosening of the implant" as possible risk factors in combination with the implantation of a hip prosthesis.The executed investigation steps give no indication that the device failed to match specification at the time of manufacturing.However, based on available information it is not possible to determine the root cause for the reported issue conclusively.The need for corrective action is not indicated.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the devices in scope be returned.

• Brand Name: SL-PLUS STEM LATERAL 4 NON-CEMENTED
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9252705
• Report Number: 9613369-2019-00082
• Device Sequence Number: 2030348
• Product Code: LZO
• UDI-Device Identifier: 07611996078046
• UDI-Public: 07611996078046
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: 75002756
• Device Catalogue Number: 75002756
• Device Lot Number: C0602511
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 75003589 BICON-PLUS PE INSERT/ LOT: 0512.02.7640
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR