MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/63; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	75023366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a piece broke off the while trialing during surgery.No significant delay was recorded.Backup was available.
Additional Manufacturer Narrative
A polarcup trial insert, navigation 22/63 was returned for investigation.Review of the production documentation did not find any deviation from standard operating procedure which could explain the reported failure.The complaint history review did not reveal other complaints concerning devices of the reported batch.Visual inspection of the returned device confirms damage.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.The reported device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT, NAV 22/63
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9317552
• Report Number: 9613369-2019-00090
• Device Sequence Number: 18984311
• Product Code: LPH
• UDI-Device Identifier: 07611996112559
• UDI-Public: 07611996112559
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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 Catalogue Number: 75023366
• Device Lot Number: A64063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1