MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL 47 CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75100453
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.The reason was the cup became loose.Cup and insert were removed.No delay to procedure.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to loosening of the polarcup shell.The device intended for use in treatment was not returned for investigation nor has a batch number been communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.No medical records have been received on this complaint.The reported event could not be assessed and a thorough medical assessment could not be performed.A review of the batch record could not be conducted due to the missing batch number.There are no other complaints reported for this device.Review of the risk management documentation verifies the failure mode and severity of the reported issue.The ifu (lit.No.12.23 ed.05/16) identifies "loosening" as a known risk factor in combination with a hip arthroplasty.Based on available information the root cause for the reported issue cannot be identified and stays undetermined.The need for corrective action is not indicated.Smith + nephew will continue to monitor the device for similar issues.The complaint will be reopened should additional information be received.

• Brand Name: POLARCUP SHELL 47 CEMENTED
• 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: 9687440
• Report Number: 9613369-2020-00023
• Device Sequence Number: 2401333
• Product Code: LPH
• UDI-Device Identifier: 07611996118445
• UDI-Public: 07611996118445
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75100453
• Device Catalogue Number: 75100453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERT 75018955, LOT UNKNONW; INSERT 75018955, LOT UNKNONW
• Outcome Attributed to Adverse Event: Required Intervention