MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 75004650

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the polarstem holder would not hold the final stem screw and the core remains stuck inside.No patient injury or other complications were reported.

Event Description

It was reported the polarstem holder would not hold the final stem screw and the core remains stuck inside.Problem discovered during office inspection.No case/patient involvement.

Manufacturer Narrative

Corrected event description.Added lot number.Additional information received indicates that the problem was discovered during office inspection.No case/patient involvement.As such, this event has been reassessed as non-reportable.

• Brand Name: POLARSTEM STEM INSERTER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau, ; SZ
• MDR Report Key: 7759679
• MDR Text Key: 116709388
• Report Number: 9613369-2018-00043
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75004650
• Device Lot Number: D59986
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1