MAUDE Adverse Event Report: SYNTHES GMBH FEMORAL NECK SYSTEM PL 2 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.268.000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2021 the patient underwent right hip hemiarthroplasty and removal of the hardware.Upon inspection of the hardware the depuy synthes femoral neck system had broken completely through the plate.The patient struggled from this procedure and suffered significant swelling in his bilateral lower extremities which was caused by deep vein thrombosis in his popliteal vein.The patient subsequently developed an infection which required a third procedure to remove the hardware and put in an antibiotic spacer on (b)(6) 2021.On (b)(6) 2021 the patient died due to cardiac arrest, anemia post op, septic right hip and thrombosis of the left arm and right leg.On or about (b)(6) 2020 the patient suffered a fall at his home, while carrying a few gallons of water on his property which included a sloping driveway.X-ray reported a right intertrochanteric fracture and a ct which concluded that he had impacted comminuted right intertrochanteric fracture.On (b)(6) 2020 the patient underwent open treatment of the right femoral neck fracture with a screw and side plate.On (b)(6) 2021 the patient complaints of worsening right hip pain and lower extremity edema.Stated the pain was so bad, he was unable to stand, the pain being worse along the inguinal crease.On january 04,2021 he reiterated his worsening pain and had to ambulate with a walker.From (b)(6) 2021 to (b)(6) 2021 the patient was back at the hospital with right hip pain that was constant.He stated that he had suffered no falls or injuries since the surgery.During his 3-day stay, was given x-rays, an mri of his lumbar spine without contrast and had a fluoroscopy and epidurogram with steroid injection at l2-l3.He was then discharged to a skilled nursing facility.On (b)(6), 2021 the patient returned to the healthcare facility where he complained of continued pain and trouble ambulating.He also stated that his surgical wound had an odor.He returned to the rehab center where he remained for a month until he suffered a fall.On (b)(6) 2021 he was found to have an infected right total hip arthroplasty, surgical wound dehiscence, a uti, acute metabolic encephalopathy and a stage iii pressure ulcer on his right heel.This report involves one femoral neck system plate 2 hole - sterile.This is report 5 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added patient date of birth.Added patient history and diagnostic/lab data.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that femoral neck system pl 2 hole - sterile was broken in two pieces.The breakage occurred at one of the threaded holes.Both broken fragments are visible in the provided evidence.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for femoral neck system pl 2 hole - sterile.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part number: 04.268.000s-us lot number: 30p4207 manufacturing site:grenchen release to warehouse date: 10 december 2019 expiry date: 31 october 2029 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: updated device manufacture date.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected: d4 primary udi number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FEMORAL NECK SYSTEM PL 2 HOLE - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15769718
• Report Number: 8030965-2022-09570
• Device Sequence Number: 12045190
• Product Code: KTT
• UDI-Device Identifier: 10886982274458
• UDI-Public: (01)10886982274458(17)291031(10)30P4207
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.268.000S
• Device Catalogue Number: 04.268.000S
• Device Lot Number: 30P4207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 12/15/2022; 04/06/2023; 07/07/2023; 08/23/2024
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/08/2022; 12/16/2022; 04/21/2023; 07/25/2023; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 44-SILE.; 5.0 TI LCKNG SCR SLF-TPNG T25 SD 44-SILE.; ANTIROTATION SCR FEM NECK 105 LNTH - S.; BOLT FOR FEMORAL NECK SYS 105 LENGTH-S.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male