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

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

Patient Problem Osteolysis (2377)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown construct: lcp/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: tomaszewski r., rutz e., mayr j., dajka j., (2020) surgical treatment of benign lesions and pathologic fractures of the proximal femur in children, archives of orthopaedic and trauma surgery volume xxxx, pages 1-10 (poland).This retrospective study aims to describe the indications, types of treatment, and outcomes of benign tumors and tumor-like lesions of the proximal femur in children and adolescents.During a 17-year period (january 1, 2002, to december 3, 2018), 30 patients, 23 boys and 7 girls (median age 10.5 years; range 1.1¿17.8 years) with benign tumors and tumor-like lesions of the proximal femur treated with open curettage, allogenic bone grafting, and plate fixation were enrolled in the study.In all children, we performed tumor curettage with adjuvant highspeed drilling and allogenic bone grafting, supplemented with artificial bone graft substitutes (calcibon®, biomet, warsaw, poland).Overall, 22 of 30 patients underwent internal fixation of the proximal femur by implantation of an lcp pediatric hip plate ® (depuysynthes, johnson & johnson, new brunswick, nj, usa).In 4 patients each, we inserted either a locking plate or an angular plate.After surgery, the patients were allowed to walk using two crutches without weight-bearing for an average of 31 days (range 20¿63 days).All patients underwent radiologic examination on the first day after surgery and at 6, 12, and 20 weeks after surgery.After this period, the frequency of radiologic checkups was determined individually.Median follow-up lasted 87 months (24¿156 months).The following complications were reported as follows: in 4 of 30 patients, we observed limb length discrepancies (median 1.25 cm; range 1.0¿2.0 cm).A case of a (b)(6) year old boy (patient no.2) with the largest discrepancy required drill epiphysiodesis of the other limb at the level of the distal femur 20 months after primary surgery.A case of (b)(6) year old boy (patient no.5) had grade 2 bone healing, incomplete healing with marginal cortex thickening and small residual areas of osteolysis, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.8) had grade 3 bone healing, recurrence with large areas of osteolysis and cortex thinning, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.11) had grade 3 bone healing, recurrence with large areas of osteolysis and cortex thinning, according to capanna¿s classification.Shortly thereafter we removed the plate.A case of a (b)(4) year old boy (patient no.14) had a fair result (14 points) at the follow-up examination 12 months after surgery according to merle d¿aubigné and postel score.This patient had (grade 3) bone healing, recurrence of with large areas of osteolysis and cortex thinning, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.16) had grade 2 bone healing, incomplete healing with marginal cortex thickening and small residual areas of osteolysis, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.20) suffering from abc achieved bone healing but developed deep wound infection 11 months after surgery.Due to completed bone consolidation, we removed the php plate and performed surgical wound debridement combined with deep tissue sampling for microbiologic analysis.Subsequently, the patient received antibiotics and achieved stable bone healing and cure of infection.A case of a (b)(6) year old boy (patient no.22) had grade 3 bone healing, recurrence with large areas of osteolysis and cortex thinning, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.23) had grade 2 bone healing, incomplete healing with marginal cortex thickening and small residual areas of osteolysis, according to capanna¿s classification.A case of a (b)(6) year old boy (patient no.26) ) had grade 2 bone healing, incomplete healing with marginal cortex thickening and small residual areas of osteolysis, according to capanna¿s classification.A case of a (b)(6) year old girl (patient no.30) ) had grade 2 bone healing, incomplete healing with marginal cortex thickening and small residual areas of osteolysis, according to capanna¿s classification.This report is for an unknown synthes lcp pediatric hip plate ®.

• Brand Name: UNK - CONSTRUCTS: LCP
• 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: 11931199
• MDR Text Key: 266656707
• Report Number: 8030965-2021-04539
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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: 05/27/2021
• 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