MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, SLOTTED 28/51; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75000666
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the instrument broke while trialing intraoperatively.No backup was available but the procedure could be successfully completed with the same device.Therefore, no time was added to the procedure.
Additional Manufacturer Narrative
It was reported that a polarcup trial insert, slotted 28/51 (art.No.75000666 / batch no.Unknown) was found broken while trialing intraoperatively.No backup was available but the procedure could be successfully completed with the same device.Therefore, no time was added to the procedure.The device, used in treatment, was not returned for investigation.Hence the product evaluation could not confirm the reported failure mode.The review of the batch record and the complaint history review could not be performed since the batch number of the complaint device is unknown.Based on the conducted investigation, the root cause could not be determined conclusively.In case additional information will become available, the investigation will be reopened.No further actions are deemed necessary.Smith+nephew will continue to monitor for similar issues.

• Brand Name: POLARCUP TRIAL INSERT, SLOTTED 28/51
• 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: 9808772
• Report Number: 9613369-2020-00052
• Device Sequence Number: 19027081
• Product Code: LPH
• UDI-Device Identifier: 07611996116809
• UDI-Public: 07611996116809
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2021

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: No Information
• Device Model Number: 75000666
• Device Catalogue Number: 75000666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/06/2020; 03/17/2021
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/13/2020; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1