• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971)
Event Date 12/23/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details, demographics regarding the additional events. Attempts are being made to clarify the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon product (prolene mesh) involved caused and/or contributed to post-operative complications (dislocation of prothesis, deep infection, wound complications/failure of coverage, extension lag, aseptic wound necrosis and wound dehiscence) described in the article? please specify. Does the surgeon believe there was any deficiency with the ethicon products (prolene mesh and ethibond suture) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (dislocation of prothesis, deep infection, wound complications/failure of coverage, extension lag, aseptic wound necrosis and wound dehiscence). Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. If available, please provide what product codes/lot numbers of prolene mesh and ethibond suture were used in these cases. Citation: journal of clinical orthopaedics and trauma. 2021; 16: 195-201. Doi: https://doi. Org/10. 1016/j. Jcot. 2020. 12. 029. Please see article. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Events were submitted 2210968-2021-03156.

 
Event Description

Title: outcomes of major musculoskeletal oncological reconstructions using prolene mesh-a retrospective analysis from a tertiary referral centre the aim of this retrospective study from a prospectively maintained bone tumor database is to find out whether use of prolene mesh for soft tissue reconstruction following resection of bone tumors (1) enhances the stability of the reconstruct or (2) increases the risk of deep infection. Between january 2017 to june 2019, a total of 116 patients (68 males and 48 females; median age = 22. 5 years) underwent soft tissue reconstruction following resection of bone tumors. 39 patients had tumors of proximal tibia, 23 of proximal femur, 25 of proximal humerus, 24 of pelvis, and five tumors at other sites. Approximately two-thirds (62. 9%) of our patients underwent endoprosthetic reconstruction while the rest underwent either biological or cement spacer reconstructions. Surgery was performed using prolene mesh (ethicon) in all cases and interrupted nonabsorbable sutures (ethibond no. 5; ethicon) in proximal femur endoprosthetic reconstruction. Reported complications included in the proximal femur endoprosthesis were dislocation of prosthesis (n=2), one was managed with closed reduction under anaesthesia followed by traction for 6 weeks; the other also had deep infection (n=1) which required aggressive debridement, prosthesis and mesh removal and cement spacer; wound complications/failure of coverage (n=3) which were managed conservatively. In the proximal tibia endoprosthesis, extension lag (n=8) with a mean of 2. 3° was reported and mean flexion at the knee was 94. 1° (range 70-110°); aseptic wound necrosis (n=8), of which only one required debridement and split thickness skin grafting (stsg). In the pelvis reconstruction, deep infection (n=2) which required debridement and mesh removal; wound dehiscence (n=1) which was managed conservatively with regular dressings. In the other group, deep infection (n=1) was observed. In conclusion, prolene mesh is a useful tool to reconstruct the soft tissue defects following bone tumor resections. It is readily available, reliable and provides reproducible results, with no added risk of wound complications.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11635318
MDR Text Key244491830
Report Number2210968-2021-03157
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/08/2021 Patient Sequence Number: 1
-
-