MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM 7 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Model Number	11000171
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to loosening of the stem.Implantation took place in 2011.

• Brand Name: SL-PLUS MIA STEM 7 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• MDR Report Key: 7532819
• Report Number: 9613369-2018-00032
• Device Sequence Number: 1704293
• Product Code: LZO
• UDI-Device Identifier: 07611996078916
• UDI-Public: (01)07611996078916(17)180510(10)B1133338
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2018
• Device Model Number: 11000171
• Device Catalogue Number: 75001945
• Device Lot Number: B1133338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 04/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/28/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR