MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP TRIAL INSERT, NAV 22/61; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this instrument broke while being used, while adjusting the implant in position.No pieces fell into the patient's wound and therefore, no pieces left in patient.No backup was available nor required since the device broke at the end of its use.No delay was recorded.
Additional Manufacturer Narrative
A polarcup trial insert, nav 22/61 (article no.75023365 / batch no.B69641) was reported due to fracture of the complaint device during surgery, no pieces fell into the patient¿s wound.The device, used in treatment, was returned for investigation.The visual inspection could confirm the reported failure mode.A review of the batch record showed no deviations from the standard manufacturing process.A review of the complaint history revealed no other complaint for the batch in question.Based on the conducted investigation, the root cause could not be determined conclusively.No further actions are deemed necessary.Smith+nephew will continue to monitor for similar issues.The complaint device will be discarded.

• Brand Name: POLARCUP TRIAL INSERT, NAV 22/61
• 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: 9757090
• Report Number: 9613369-2020-00031
• Device Sequence Number: 2574482
• Product Code: LPH
• UDI-Device Identifier: 07611996112542
• UDI-Public: 07611996112542
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2020

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: No Information
• Device Model Number: 75023365
• Device Catalogue Number: 75023365
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1