MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: RECONSTRUCTION; PLATE,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problems Nerve Damage (1979); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: stiehl b., saluja r., diener t., (2000), reconstruction of major column defects and pelvic discontinuity in revision total hip arthroplasty , the journal of arthroplasty vol.15 no.7,pages 849-857 (usa).This study aims to review a long-term experience using a combination of pelvic reconstruction plates and bulk allografts to deal with unusually severe problems, such as pelvic discontinuity and major column loss in which the entire acetabular wall became nonsupportive after failed arthroplasty and reconstruction problems.From january 1988 until july 1996, a total of 17 patients (3 male and 17 female) treated for entire loss of a pelvic column, pelvic discontinuity, or both were included in the study.Fixation used a posteriorly placed ao 4.5-mm pelvic reconstruction plate of 10 to 12 holes in 9 cases of pelvic discontinuity and 5 cases of posterior column bone loss while anterior column fixation used an 8- to 12-hole 3.5-mm ao pelvic reconstruction plate.Average follow-up was 83 months.The following complications were reported as follows: a case of a female patient number 6 , age at time of follow up was (b)(6) year old , treated with anterior plating had dislocation.A case of a femael patient number 14 , age at time of follow-up was (b)(6) year old, treated with posterior plating ,underwent revision and had late infection and underwent additional exploration of the sciatic nerve for late entrapment at 46 months and 24 months caused by migration of screws from the posterior column plate.A case of a femal patient number 16, age at time of follow-up was (b)(6) year old, treated with posterior plating ,underwent revision and had late sciatic nerve palsy, implant loosening and additional exploration of the sciatic nerve for late entrapment at 46 months and 24 months caused by migration of screws from the posterior column plate.A case of a male patient number 17 , age at time of follow-up was (b)(6) year old, treated with posterior plating, had dislocation.Two patients suffered from bladder infections postoperatively, 1 developing late infection of the prosthesis with the same organism isolated from infected urine.Another patient developed superficial phlebitis of the lower leg that resolved with rest and anticoagulant therapy.A case of a female patient number 5, age at follow up was (b)(6) year old, treated with anterior and posterior plating underwent revision and had acute infection and dislocation.A case of a female patient number 9, age at time of follow up was (b)(6) year old, treated with anterior and posterior plating underwent revision and had a dislocation.A case of a female patient number 12 ,age at time follow-up (b)(6) year old,treated with anterior and posterior plating underwent revision and had dislocation.Death: a case of a male patient number 3 who underwent anterior column fixation had dislocation and late sciatic nerve palsy and later on died.A case of a female patient number 4 who underwent anterior and posterior fixation with plates had a revision and acute infection, later on died.A case of a female patient number 10, age at time of follow up was (b)(6), treated with anterior and posterior plating had dislocation.A case of a female patient number 13 ,age at time of follow up was (b)(6), treated with posterior plating had dislocation.A case of a female patient number 7, who underwent anterior and posterior fixation with plates died.A case of a female patient number 11, who underwent anterior and posterior fixation with plates died.A case of a female patient number 15 , who posterior fixation with plates died.This report is for one (1) unknown synthes pelvic reconstruction plate.This is report 9 of 10 for (b)(4).

• Brand Name: UNK - PLATES: RECONSTRUCTION
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8879268
• MDR Text Key: 153850465
• Report Number: 2939274-2019-59636
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• 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
• Date Manufacturer Received: 07/12/2019
• 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): Death; Required Intervention