MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 4 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75002701
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).
Additional Manufacturer Narrative
H10: it was reported that after a bilateral total hip replacement surgery performed (only one is from smith and nephew) on (b)(6) 2010, the clinical subject passed away on (b)(6) 2020.The device, used in treatment, was not returned for investigation as it is still in the corpse.A product evaluation could therefore not be performed.A review of the production documentation for the batch in scope was performed and did not reveal any deviation from the standard operating procedure.No further complaints for the batch in scope were reported so far.Hence, there is no indication that the device failed to match specification at the time of manufacturing.A review of past corrective actions was performed as well.No further escalation is required.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.A risk management review and a review of the device labeling were performed, death is not anticipated from the intended use of the device.A thorough medical assessment could not be performed due to limited information available.The provided information offers no insight into the reported death.Should any additional relevant supporting medical information be provided, this compliant would be re-assessed.Based on the available information it is not possible to speculate about factors which could have contributed to the reported event.The cause of the patient¿s death, 10 years after a bilateral total hip replacement surgery remains unknown.Based on the performed investigations, a relationship between the reported event and the device cannot be confirmed.No further actions are deemed necessary.Smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information be received.Internal complaint reference number: (b)(4).

• Brand Name: SL-PLUS STANDARD STEM 4 NON-CEMENTED
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14074503
• Report Number: 1020279-2022-01766
• Device Sequence Number: 2646829
• Product Code: KWY
• UDI-Device Identifier: 07611996078664
• UDI-Public: 07611996078664
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072852
• 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,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 10/16/2015
• Device Model Number: 75002701
• Device Catalogue Number: 75002701
• Device Lot Number: F0810096
• Was Device Available for Evaluation?: No
• 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: 04/26/2022; 06/10/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/26/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2008
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 93 KG