MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 6; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLY CEMENT OR NON-POROUS,UNCEMENT

Catalog Number	75000191
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a spiral fracture occurred when the patient stood up and twist leg.The stem was replaced as consequence.
Additional Manufacturer Narrative
It was reported that a revision surgery had to be performed due to a periprosthetic fracture of a sl-plus mia stem (75000191).No similar complaints have been found for the present part number in combination with the present failure mode.A device history record (dhr) review could not be performed since the batch number remained unknown.Also, no medical assessment could be performed since no medical documents were received for investigation.Since the part has not been returned either, the root cause could not be determined conclusively due to insufficient information.No further actions are deemed necessary as a result of the performed investigation.In case more information becomes available in the future, this complaint will be reopened.

• Brand Name: SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 6
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLY CEMENT OR NON-POROUS,UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7845083
• Report Number: 9613369-2018-00057
• Device Sequence Number: 13836811
• Product Code: LZO
• UDI-Device Identifier: 07611996092936
• UDI-Public: 07611996092936
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: Lay User/Patient
• Device Catalogue Number: 75000191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: Required Intervention