MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,

Model Number	76539166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that after a bilateral thr surgery performed (only one is from smith and nephew) on (b)(6) 2010, the clinical subject passed away on (b)(6) 2020.The cause of death is unknown.Further information is not available at the time.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).(b)(6).
Additional Manufacturer Narrative
H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it should be noted the patient had comorbidities that were reported as ongoing the year prior to their death that could have contributed to their death.Based on the information provided the cause of death cannot be confirmed.We cannot conclude the s+n products were related to the cause of death.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The patient died 10 years after the implantation of the complained device and the cause of death is unknown.There is no indication that the implant contributed in any manner to the death of the patient.Without details of the alleged fault, malfunction or death, no probable cause can be delineated that relates the event with the device.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: case-2022-00098571-1.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,
• 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: 14103405
• Report Number: 1020279-2022-01814
• Device Sequence Number: 17699729
• Product Code: LZO
• UDI-Device Identifier: 03596010566966
• UDI-Public: 03596010566966
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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 Expiration Date: 09/28/2019
• Device Model Number: 76539166
• Device Catalogue Number: 76539166
• Device Lot Number: 09JT35811
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2009
• 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: 71331752/R3 36MM ID INTL DLT CER LNR 52MM/10ET4251; 71332525/REF SPHER HEAD SCREW 25MM/10DM11868; 71332530/REF SPHER HEAD SCREW 30MM/10CM03845; 71335552/R3 3 HOLE ACET SHELL 52MM/10EM14114; 75002701/SL-PLUSSTANDARDSTEM4NON-CEMENTED/F0810096
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 93 KG