MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74120160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	08/18/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case: (b)(4).
Event or Problem Description
It was reported that during a primary surgery when attempting the birmingham procedure, the original planned surgery was aborted due to intraoperative bleeding which required the femoral neck cut to be made.There was felt to be a significant branch of the femoral circumflex vessels that caused this intraoperative bleeding.The blood loss was controlled with the use of cell saver.The patient received 250 cc of blood reinfused during this procedure.After adequate hemostasis, the procedure was finished converting the birmingham procedure to a total hip arthroplasty.The patient was returned to the recovery room in satisfactory condition.
Additional Manufacturer Narrative
H3, h6: it was reported that a change in a primary surgery technique was performed due to an intraoperative bleeding requiring the femoral neck cut to be made.As of today, the devices, all of which were used in treatment, remain implanted and therefore cannot be tested.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the devices.A review of historical complaints data was performed for the cup using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.No other similar complaints have been identified for the cup.However, this failure will continue to be monitored.As no device part and batch numbers were provided for the head, a complaint history review and definite escalation actions review could not be performed.As no device batch numbers were provided for investigation neither for the cup nor the head, manufacturing record review could not be performed.If more information is received, this investigation will be reopened.The review of the most recent ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.The available medical documents were reviewed.Intraoperative bleeding is a known risk of any surgery and is related to the surgical procedure and not the device.Therefore, it cannot be concluded the intraoperative bleeding and subsequent blood transfusion was related to the implant.The surgery was successfully completed by changing from a birmingham hip resurfacing to a total hip arthroplasty.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.A definitive root cause cannot be determined.Based on the limited information provided, we are unable to speculate on specific factors known to contribute to the alleged fault.All surgeons using the bhr implant system are expected to have undergone training and be familiar with the implant components, instruments, procedure, clinical applications, adverse events, and risks associated with the bhr system.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: ACETLR CUP HAP 60MM W/ IMPTR
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17303081
• Report Number: 3005975929-2023-00103
• Device Sequence Number: 15243255
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 74120160
• Device Catalogue Number: 74120160
• Device Lot Number: UNKNOWN
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male