MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP CONDYLAR; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - plates: lcp condylar/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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: nierenberg g, et al.(2020), knee arthroplasty with hardware removal: complication cascade.Is it preventable?, bmj case rep, volume 13, pages 1-4 (israel).This reports a case of an (b)(6) year-old female patient with constitutional valgus who was electively admitted for right knee joint replacement due to aggravated pain due to primary osteoarthritis involving the lateral compartment and patellofemoral joint.7 years earlier, she underwent a right total hip replacement (thr).1 year afterward, she fell from a standing position resulting in a supracondylar fracture of the ipsilateral femur.She subsequently underwent open reduction internal fixation with an unknown synthes locking compression plate condylar plate.At 7 months, an uneventful follow-up with a slightly delayed union ensued.An attempt was made to remove the unknown synthes locking compression plate condylar plate for femoral guide rod insertion into the medullary canal for the total knee replacement.During the removal, difficulties were encountered due to a worn hex head screw hole socket; another screw breakage with complete detachment of the screw head necessitated ¿broken screw extractor set¿ usage, a carbide drill and special tools for complete hardware removal.These efforts resulted in iatrogenic intraoperative fracture of the femur.Total knee replacement (depuy sigma, j&j, warsaw, indiana, usa) was commenced with temporary reduction and final stabilisation of the femur fracture with a competitor¿s condylar plate augmented with allogenic bone graft.Postoperatively, non-union of the femur fracture developed twice with fatigue failure of the plate fixation device in both instances.Refixation of the femur was performed on both occasions and additional bone healing augmentation measures were performed for each subsequent surgery.In the last surgery, removal of the competitor¿s broken plate was followed by refixation of the femur with an unknown synthes locking compression plate, additionally augmented with an unknown synthes low contact dynamic compression plate (lc-dcp) on the anterior cortex of the femoral shaft.Both bone marrow aspirate concentrate and allogenic bone were supplemented to stimulate callus formation.At 14 months, solidly mineralised callus formation was observed.The patient resumed ability to walk with a single crutch and maintains an independent life style including basic outdoor activities.At 4 years follow-up, during which three major operations were performed within 2.5 years, the patient was fully independent and able to walk freely around the house.She demonstrated a leg length discrepancy of 1.5 cm with a very slight limp and active range of knee motion of 0°¿100°.Walking aids were in use intermittently in the house.This report is for the unknown synthes locking compression plate condylar plate and screws, unknown synthes locking compression plate and unknown synthes low contact dynamic compression plate.This report is for (1) unk - plates: lcp condylar.This is report 1 of 6 for complaint (b)(4).

• Brand Name: UNK - PLATES: LCP CONDYLAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12528358
• MDR Text Key: 273789242
• Report Number: 8030965-2021-08028
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR