MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP XLPE INSERT 55/28 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75018959
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a 1st stage revision hip arthroplasty for infection.Implants were explanted and sent to local pathology for sonification/infection identification.Sinus track from skin wound into deep tissue/joint was noted during surgery, along with 'foul odour' and heamoserous ooze/pus.Type of bacteria not known at time of surgery.
Additional Manufacturer Narrative
H3, h6: it was reported that a patient underwent a first stage revision hip arthroplasty for infection.The polarcup shell (75100442), polarcup insert (75018959) and polarstem (75002115) used in treatment have not been returned for investigation.An evaluation of the complained devices could therefore not be conducted and the reported failure mode could not independently be confirmed.A medical investigation was conducted.It was communicated that no further information would be provided due to lack of consent.Reportedly, infection was the root cause of the reported events; however, no supporting documentation was provided and the ¿type of bacteria¿ was unknown at the time of surgery.The patient impact beyond the reported infection and subsequent 1st stage revision could not be determined.No further medical assessment could be rendered at this time.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The instructions for use lists infection as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on available information the root cause for the reported infection is attributed to a known inherent risk of the devices.However, the executed investigation does not indicate that one of the devices failed to match specification at the time of manufacturing.The need for corrective action is therefore not indicated.Nevertheless, smith + nephew will continue to monitor these devices for similar issues.This complaint will be reopened should additional information or the devices be received.

• Brand Name: POLARCUP XLPE INSERT 55/28 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11692502
• Report Number: 9613369-2021-00161
• Device Sequence Number: 4331137
• Product Code: LPH
• UDI-Device Identifier: 07611996111491
• UDI-Public: 07611996111491
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 75018959
• Device Catalogue Number: 75018959
• Device Lot Number: B2016441
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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: 75017233 - POLARCUP CORT SCREW 4.5X44 NON CEM; 75017234 -POLARCUP CORT SCREW 4.5X48 NON CEM
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 43 YR