MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM CEMENTLESS STEM LAT TI.HA 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER UNCEMENTED

Model Number 75100474

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/04/2019

Event Type  Injury  

Event Description

It was reported that patient had periprosthetic hip fracture and a loose stem.A revision surgery was performed to resolve the event.

Manufacturer Narrative

A revision surgery was reported due to periprosthetic fracture.The device revised was a polarstem cementless lat stem ti/ha size 1 which was used for treatment and was not sent back for investigation.Furthermore no clinical documentation have been received.Therefore a thorough product or medical investigation could not be performed.The batch records did not reveal any deviation which could have led to the reported failure.No other complaint was found for the reported batch.Bone fracture is a known risk for s+n and is mentioned in the corresponding ifu for hip implants (b)(6) - ed.(b)(6).At that time of investigation the root cause remains undetermined.Should medical/clinical records being received, the complaint will be re-opened.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 1
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9489013
• MDR Text Key: 171815866
• Report Number: 9613369-2019-00105
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• Combination Product (y/n): N
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: B1914212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD: 76539166, LOT 19HT26346; HEAD: 76539166, LOT 19HT26346
• Patient Outcome(s): Required Intervention