MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM WITH TI/HA 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Model Number	11000427
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation caused by the technical failure.
Additional Manufacturer Narrative
Corrected fields: (manufacturer report number corrected to 9613369-2018-00233).
Additional Manufacturer Narrative
Manufacturer report number corrected to 9613369-2018-00233.(b)(4).

• Brand Name: SL-PLUS MIA STEM WITH TI/HA 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar TN 6340 ; SZ 6340
• MDR Report Key: 7292385
• Report Number: 1020279-2018-00233
• Device Sequence Number: 1211644
• Product Code: LZO
• UDI-Device Identifier: 07611996092790
• UDI-Public: 07611996092790
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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: 09/16/2024
• Device Model Number: 11000427
• Device Catalogue Number: 75000177
• Device Lot Number: C1714009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 02/16/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/01/2018; 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