MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM VALGUS TI/HA 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 75102074

Device Problem Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 09/14/2018

Event Type  Injury  

Event Description

It was reported that patient underwent primary right thr direct anterior approach on (b)(6) 2018.Post operative x-ray showed femoral component penetrated femoral cortex.Revision surgery was required to correct the condition.

Manufacturer Narrative

Results of investigation: a complaint was reported for a polarstem valgus ti/ha.It was reported that post operative x-rays showed the femoral component penetrating the femoral cortex.A revision surgery was required to correct the condition.No part was returned for investigation.The documentation available for the reported stem was reviewed.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No similar complaint was reported for this batch of products.No medical documents were communicated.Based on the available information, no specific root cause could be determined.There is however to the best of our knowledge no indication that the device failed to meet specifications at the time of manufacturing.No further actions have been initiated.If the explants or additional information becomes available in the future this investigation will be reopened.

• Brand Name: POLARSTEM VALGUS TI/HA 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7963706
• MDR Text Key: 123669299
• Report Number: 9613369-2018-00068
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• 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: 01/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: 75102074
• Device Lot Number: B1511417
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/13/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PN:71343203 LN:18EM06010
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR