MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 36MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS

Model Number	71303600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that a revision surgery was performed due to an infection, 2 months post total hip arthroplasty.The joint was washed out, and the femoral head was explanted.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to an infection 2 months post total hip arthroplasty.The joint was washed out and the poly and the femoral head were explanted.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record and sterilization documentation review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The lot is unknown for this part.No medical documents were received for investigation, therefore, the source of the unspecified infection could not be fully assessed.Without medical records provided, the cause of the reported event cannot be determined at this time.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: COCR 12/14 FEM HEAD 36MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10902308
• Report Number: 1020279-2020-06690
• Device Sequence Number: 19198092
• Product Code: LPH
• UDI-Device Identifier: 03596010479983
• UDI-Public: 03596010479983
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: Lay User/Patient
• Device Model Number: 71303600
• Device Catalogue Number: 71303600
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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: UNKNOWN STEM IMPLANT; UNKNOWN STEM IMPLANT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention