MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: DHS/DCS; PLATE, FIXATION, BONE

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

Patient Problems Joint Dislocation (2374); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: qiyong c., et al (2020) classification and treatment of acetabular fracture combined with anterior dislocation of hip joint, chinese journal of orthopedic trauma vol.22 no.12 , pages 1-10 (china).This retrospective study aims to investigate the classification and treatment of acetabular fracture combined with anterior dislocation of hip joint.Between july 2005 and march 2018, clinical data of 12 patients (7 males and 5 females) aged 24-80 years, with mean one of 49.6 years old with acetabular fracture complicated with anterior dislocation of hip joint who were diagnosed and treated in the department of trauma and orthopedics, beijing jishuitan hospital were analyzed.There were 5 cases of treatment, 6 cases of surgical internal fixation, and 1 case of primary joint replacement.12 cases of acetabular fractures with hip plate and screw (johnson & johnson, usa) internal fixation, of which 2 cases of patients with anterior dislocation, and with reference to the epstein classification of anterior dislocation of the hip joint epstein classification of femoral neck and intertrochanteric fractures were one-stage fixed with dynamic hip screws (johnson & letournelet acetabular anterior column fracture classification, johnson & johnson, usa).One elderly patient underwent hip arthroplasty at one stage.Patients were followed up in 2 months (range, 3 to 46 months).The following complications were reported: a case of a 67-year-old male (case no.1) who underwent kocher lange beck approach + orif.Postoperative x-ray showed uncorrected separation and displacement of acetabular fracture, with obvious gap ; ct three-dimensional reconstruction picture showed atypical anterior column fracture, with poor reduction and poor functional outcome.Postoperative x-ray showed severe osteoarthritis at 2 years.A case of 41-year-old male (case no.3) who underwent ilioinguinal approach +orif had poor reduction quality at follow-up time and recurrent dislocation.A case of a 47-year-old male (case no.8) who underwent iliofemoral approach + orif had poor functional outcome.A case of an 80-year-old male (case no.11) who underwent hip arthroplasty had poor reduction quality at follow up.Figure 2 : type b acetabular fracture combined with anterior dislocation of hip joint: female patient, 40 years old, left hip injury caused by falling injury, x-ray (a) and ct three-dimensional reconstruction picture (b) showed left hip iliac dislocation, peri-iliac fracture, the iliac wing, pelvic margin and closed hole ring were intact; the coronal ct picture after closed reduction confirmed that the upper wall compression fracture was not reduced (c); 4 months later, the x-ray (d) and ct three-dimensiona reconstruction picture (e) showed fracture malunion, dislocation recurrence.This report is for an unknown synthes dynamic hip screw and unknown synthes hip plate and screw.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - constructs: dhs/dcs.This report is 5 of 8 for pc (b)(4).

Manufacturer Narrative

Product complaint # pc : (b)(4).This report is for an unk - constructs: dhs/dcs/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13055316
• MDR Text Key: 286345271
• Report Number: 8030965-2021-10370
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention