MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to a fractured proximal femur plate, approximately three (3) years nine (9) months from initial surgery.Osteoporotic bone was noted during the revision surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ slovenia.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The plate and the fixation screws were returned for investigation.The event can be confirmed as the plate is fractured and the fracture line is located through a screw hole.Both surfaces of the plate show some scratches.The most distal part of the plate is bent.The fractures surfaces of the plate are damaged and present some scratches and polished area most likely due to relative contact of the two pieces after fracture.The edges of the fracture surface are sharp.The overall shape of the plate in the area of the fracture is straight.All these element point to a possible fatigue fracture.The threaded area of some of the screws is damaged and flattened in the area close to the head of the screws themselves.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Two undated x-ray of the left femur were received and reviewed by a radiologist.A left hip arthroplasty is present and anatomically aligned.Plate and screw fixation is present along the lateral left femur traversing a diaphyseal fracture.The plate is fractured at the same level where the previous fracture was; the latter shows signs of fracture non-union.Analysis of the retrieval found the plate to be bent in the most proximal part.The surgical technique reports that bending the plate may decrease its fatigue strength.Moreover, no information is available to determine if the plate was bent with the appropriate bending press as prescribed in the surgical technique.The provided x-rays show a non-union fracture of the femur in the area of the plate fracture.As described in the clinical evaluation report, delayed or nonunion of a fracture will subject the fracture site and osteosynthesis device to repetitive stresses that may cause eventual bending or breakage of the osteosynthesis device.In conclusion, based on the investigation of the retrievals, a plate fracture can be confirmed and most likely attributed to fatigue.Nevertheless, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that revision surgery was performed due to a fractured proximal femur plate, approximately three (3) years nine (9) months from initial surgery.During revision surgery, osteoporotic bone was noted where the previous fracture occurred (the cerclage may also have contributed to the poor healing).Because the bone did not heal back, all the weight was on the plate.The position of the screws was narrow so the force shield was narrow and caused the plate to bend.During the new implantation, they tried to expand and extend the force shield.No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The plate and the fixation screws were returned for investigation.The event can be confirmed as the plate is fractured and the fracture line is located through a screw hole.Both surfaces of the plate show some scratches.The most distal part of the plate is bent.The fractures surfaces of the plate are damaged and present some scratches and polished area most likely due to relative contact of the two pieces after fracture.The edges of the fracture surface are sharp.The overall shape of the plate in the area of the fracture is straight.All these elements point to a possible fatigue fracture.The threaded area of some of the screws is damaged and flattened in the area close to the head of the screws themselves.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Two undated x-ray of the left femur were received and reviewed by a radiologist.A left hip arthroplasty is present and anatomically aligned.Plate and screw fixation is present along the lateral left femur traversing a diaphyseal fracture.The plate is fractured at the at the same level where the previous fracture was; the latter shows sign of fracture non-union.Analysis of the retrieval found the plate to be bent in the most proximal part.The surgical technique (doc.Number 06.02013.012 rev.04) reports that "[.] bending the plate may decrease its fatigue strength".Moreover, no information is available to determine if the plate was bent with the appropriate bending press as prescribed in the surgical technique.The provided x-rays show a non-union fracture of the femur in the area of the plate fracture.As described in the clinical evaluation report.A delayed or nonunion of a fracture will subject the fracture site and osteosynthesis device to repetitive stresses that may cause eventual bending or breakage of the osteosynthesis device." in conclusion, based on the investigation of the retrievals, a plate fracture can be confirmed and most likely attributed to fatigue.Nevertheless, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Investigation updates.Complaint was reopened because of new information on the patient through correspondence with local.The patient is female, date of birth (b)(6) 1937; first revision after periprosthetic fracture on the (b)(6) 2019.On (b)(6) 2023 the incident occurred after approx.3 years and 9 months.The patient was self-sufficiently mobile with walking aids.Microbiologic testing did not confirm infection.The issue arose due to inadequate biological healing unrelated to the material.After the last surgery the patient can walk independently and can fully support her weight on the limb.The new available information do not change the outcome of the investigation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17478351
• Report Number: 0009613350-2023-00440
• Device Sequence Number: 11434552
• Product Code: HRS
• UDI-Device Identifier: 00889024292765
• UDI-Public: (01)00889024292765(17)290131(10)2982244
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.115
• Device Lot Number: 2982244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 10/09/2023; 11/14/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/06/2023; 10/30/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female