MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM (UNKN. TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 09/22/2020

Event Type  Injury  

Event Description

It was reported that, after a tha had been performed, the patient experienced an unspecified adverse event.A revision surgery was performed to explant the stem and the head.The patient outcome is unknown.

Manufacturer Narrative

It was reported that revision surgery was performed due to unknown reasons.An unknown polarstem valgus stem and 32mm head were explanted and replaced with s+n devices.The claimed articles, which intent uses are in treatment, were not sent back for investigation.Furthermore, no adequate information is available.The cause for the revision was not communicated.Clinical documentation or further product information like batch number was not made available.A thorough product history review could therefore not be performed.The risk of an unspecified failure, which leads to a revision, is covered.In our current instruction for use for hip implants (b)(6) ed.(b)(6) several mentioned side effects can lead to a revision surgery.At that time of investigation no further actions seem to be required.The root cause cannot be determined and the failure mode cannot be confirmed.If additional information should be available the complaint will be re-assessed.

• Brand Name: UNKN. POLARSTEM (UNKN. TYPE)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10679181
• MDR Text Key: 211329985
• Report Number: 9613369-2020-00210
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• 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: 11/24/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention