MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71357112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that during a right tha revision surgery performed on the (b)(6) 2022, the greater troches fracture while trying to expose the femoral component which was treated with bone graft.Additionally, during the procedure, there was concern of blood loss from the acetabular component, therefore two units of packed red blood cells were provided.The patient was stable at the end of the procedure.
Additional Manufacturer Narrative
Internal reference: case (b)(4).
Additional Manufacturer Narrative
D3 (manufacturer name), g (manufacturing site).Please note that the fei for memphis manufacturing site is 1020279.
Additional Manufacturer Narrative
After further assessment of the information gathered by the manufacturer, it was identified that this event is a duplicate of internal complaint reference number (b)(4) (manufacturing report number: 3005975929-2023-00059).As such the investigation was performed on the last mentioned complaint.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16903520
• Report Number: 3005975929-2023-00060
• Device Sequence Number: 14792197
• Product Code: MRA
• UDI-Device Identifier: 03596010559678
• UDI-Public: 03596010559678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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: 71357112
• Device Catalogue Number: 71357112
• Device Lot Number: 06AM04685A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 04/25/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 05/23/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 74120166 / LOT: 71400; PN: 74122558 / LOT: 10205; PN: 74222200 / LOT: 08BW15655
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male