MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	75100467
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to severe pain and fracture.Dr states that this revision was not caused by device but patient fell down.
Additional Manufacturer Narrative
A revision surgery was performed due to pain and fracture.A polarstem stem std ti/ha 4 non-cem was replaced.Due to the information given, it can only be assumed that a periprosthetic fracture occured.Several attempts have been made to obtain clinical/medical documents.It has been communicated that no information would be coming.Also communicated is that the doctor stated ¿this revision was not caused by device but patient fell down.¿ without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Furthermore, the article complained about is not available.A product evaluation could not be performed.The documentation review reveals no abnormalities according to the standard operating procedures.In our ifu for hips 12.23 bone fracture is a known possible side effect.A fall further favors a fracture of the bone.At that time of investigation the root cause remains undetermined due to insufficient information.If medical documents or other information get available, the complaint will be re-opened and further activities can be planned.Until then, we kindly ask you to continue reporting any anomalies with our products to the appropriate smith & nephew representative or office for investigation.

• Brand Name: POLARSTEM STEM STD TI/HA 4 NON-CEM
• 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: 8946049
• Report Number: 9613369-2019-00063
• Device Sequence Number: 3295143
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 75100467
• Device Lot Number: B1712504
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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