MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNNTM, CMN FEMORAL NAIL, CCD 130, LEFT, O 10 MM, 32 CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: ref# 47-2484-032-50; lot# 65331222; cortical screw 5.0mm.Ref# 47-2484-035-50; lot# 65167447; cortical screw 5.0 mm.Ref# 00-2232-004-18; lot# 65423172; cerclage cable.Ref# 00-2232-004-18; lot# 65304616; cerclage cable.Ref# 47-2485-095-10; lot# 3108616; lag screw 10.5 mm.G2- germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by legal that the patient underwent an initial left femur open reduction internal fixation.Subsequently, they were revised due to pain, difficulty ambulating, nonunion of bone fracture, instability and component nail fracture.Nail was exchanged with unknown component without complications, and difficulty placing unknown condyle plate.Due diligence is in progress for this event; to date no further information has been provided.
Event or Problem Description
No additional information at the moment.
Additional Manufacturer Narrative
(b)(4).No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.The review identified the following findings: (b)(6)2022.Minimal wound secretion in the middle 3rd, no signs of infection, wound cleaned with partial removal of staples.X-ray: no change in position.(b)(6)2022 6 weeks follow up, doing well, incision healing well, instructed to start bearing weight on left leg.X-ray: ¿mild dislocation of the fractured lesser trochanter with evident callus reaction at the inferior border¿.(b)(6)2023.Presents to office with persistent limp to left side after a subtrochanteric fracture of left femur no pain with movement x-ray delayed union of fracture, no change in component position strength exercises instruction given if leg length unequal may consider shoe elevation.(b)(6)2023 reports gluteal left side pain that radiates into groin, functional leg length difference, walking with forearm crutches, no trauma reported offered inpatient iv pain relief, patient chose outpatient po pain therapy (b)(6)2023 x-ray for instability findings: fracture of intramedullary nail proximally, displacement of lag screw and cerclage wire, and fracture of femoral neck component (b)(6)2023 revision report.Diagnosis: implant fracture in osteosynthetically treated pertrochanteric femur fracture on the left side general anesthesia, ebl 700ml (normal with revision) nail easily extracted; scar tissue debrided 1st attempt with ¿an 80 blade length is hammered in with a 14-lock plate and fixated with screws, the last screw just below the plate blade twisted in adam¿s arc, when tightening plate breaks out through the head in the direction of the joint.The entire osteosynthesis is dissolved again¿ new approach with 70 mm blade length.When adjusting the shaft, pay attention to the correct rotational position using the foot.The trochanter minus fragment is successively pulled down.Final x-ray shows correct position and alignment of new nail and fracture ¿the anatomic position of the lesser trochanter was no longer possible as a result of the shortening¿ drain placed (b)(6)2023 x-ray: no sings of loosening or material failure.Comorbidity of glucocerebrosidase disorder was noted as a contributing factor for the reported event.With the available information, a definitive root cause could not be determined.

• Brand Name: ZNNTM, CMN FEMORAL NAIL, CCD 130, LEFT, O 10 MM, 32 CM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 17348790
• Report Number: 0009613350-2023-00401
• Device Sequence Number: 12279065
• Product Code: HSB
• UDI-Device Identifier: 00889024299344
• UDI-Public: (01)00889024299344(17)320512(10)3109834
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-323-10
• Device Lot Number: 3109834
• Was Device Available for Evaluation?: No
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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 Sex: Female