MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LATERAL WITH TI/HA 2 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Model Number 11000338

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/29/2018

Event Type  Injury  

Event Description

User report (b)(4) reported through ansm: revision surgery due to fracture of the polarstem stem.Stem was exchanged.The patient fell down.Patient is overweight.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Event Description

User report (b)(4) reported through ansm: revision surgery due to fracture of the polarstem stem.Stem was exchanged.The patient fell down.Patient is overweight.Update 3/07/2018: polarstem is broken at the neck.Update 3/9/2018: two previous revisions of the cup was performed in 2011 and 2012.

• Brand Name: POLARSTEM STEM LATERAL WITH TI/HA 2 NON-CEM
• Type of Device: 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: 7312603
• MDR Text Key: 101466836
• Report Number: 9613369-2018-00012
• Device Sequence Number: 1
• Product Code: LZO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2014
• Device Model Number: 11000338
• Device Catalogue Number: 75002079
• Device Lot Number: KM061M41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention