MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/55; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023362
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that liner trial broke in multiple pieces during implant final impaction.Unknown delay occurrence.No backup was available.
Additional Manufacturer Narrative
A polarcup trial insert, nav 22/55 was reported because the part broke in pieces during implant final impaction.It assumed that the device was used in surgery.The complaint device was not returned for investigation.The failure mode could not be confirmed.Review of the production documentation and the complaint history review could not be performed since the production lot number is unknown.Based on the conducted investigation the root cause of the failure could not be determined conclusively.Further investigations have been initiated to better understand the issue.Smith+nephew will continue to monitor for similar issues.

• Brand Name: POLARCUP TRIAL INSERT, NAV 22/55
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9537004
• Report Number: 9613369-2019-00110
• Device Sequence Number: 11387742
• Product Code: LPH
• UDI-Device Identifier: 07611996112511
• UDI-Public: 07611996112511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 75023362
• Device Catalogue Number: 75023362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1