MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; PLATE,FIXATION,BONE

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

This report is being filed after the review of the following journal article: kondo n., et al (2020) atypical femoral fracture associated with delayed union for which the cessation of alendronate and daily administration of teriparatide contributed to fracture healing: histopathological evidence of the enhancement in bone formation parameters, modern rheumatology case reports vol.4, no.1,pages 141¿146 (japan).This study presents a case report of a patient who required revision surgery and was treated with teriparatide for delayed union.A case of (b)(6) year old woman who was diagnosed with systemic lupus erythematosus (sle) was presented.She had been treated with prednisolone (psl) since 2006.She was treated with 60 mg/ day of psl for 1 month at first, and psl was tapered by 10 mg/day every 4 weeks (40 mg/day after 2 months).Then, psl was more tapered by 5 mg/day every 4 weeks (20 mg/day after 9 months) and finally, she was maintained with 10 mg/day of psl after 14 months.For prevention of glucocorticoid-induced osteoporosis, she had also been prescribed 35 mg/ week of alendronate for 5 years.She complained of left thigh pain with inability to stand and walk just after she fell from a standing position during exercise.Her initial radiography findings showed a left atypical femoral subtrochanteric fracture.In addition, on the same radiography, a beaking was detected in her right subtrochanteric area without pain.An intramedullary nail was inserted for the left subtrochanteric aff.A third fragment was generated on the intramedullary reaming.Because the cortical bone tissue was very hard, the fracture site was displaced only 1 week after the initial surgery.Alendronate was ceased at the time of initial osteosynthesis.Revision surgery was performed 2 weeks after the initial surgery.The intramedullary nail was removed and locking compression plate-distal femur (lcp-df plate) (depuy, synthes, tokyo, japan) was applied with a left iliac bone graft.After the revision surgery, teriparatide was administered and continued for 24 months.She complied with non-weight bearing.Callus formation was detected 6 months after the revision surgery, then she was permitted 1/4 partial weight bearing (pwb) gait.After that, she was permitted 1/3 pwb 8 months after the revision surgery, then 1/2 pwb gait (10 months), and 2/3 pwb gait (1 year).Radiography revealed that fracture healing had not been achieved until 20 months.She did not have an accidental event like falling down.In addition, no local infection was detected.The screw heads in the proximal lcp-df plate broke and proximal fragment was displaced to the varus direction 1 year after the revision surgery, and a re-revision surgery was performed.The fractured site (delayed portion) was removed (25mm in length), shortened, and fixed with a compression hip screw (johnson and johnson, new brunswick, nj, usa) accompanied by an iliac bone graft from her right ilium.Eventually, fracture healing was achieved 15 months after the re-revision surgery and the patient was able to walk without support and pain.With informed consent, her harvested iliac bones were subjected to bone histomorphometry.This report is for an unknown synthes locking compression plate-distal femur (lcp-df plate).This report is for one (1) unk - plates.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10820448
• MDR Text Key: 217647503
• Report Number: 8030965-2020-08806
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR