MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); No Code Available (3191)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: liu, h.Et al.(2018), surgical strategy for benign lesions in proximal femur: internal fixation or endoprosthetic replacement, international orthopaedics, vol 42, pages 2691-2698 (china).The purpose of this study was to explore the indications for the two most frequently applied surgical procedures for benign lesions in the proximal femur.From january 2010 to january 2015, a total of 142 patients were included in the study.110 patients were stabilized with if (51 males, 59 females;mean age, 31.7 years, range 32¿84 years), and 32 patients were treated with epr (15 males, 17 females; mean age, 27.8 years, range 36¿84 years).Implants used for the if group were (depuy-synthes, paoli, ca, usa) including an anatomical plate (16), dynamic hip screw (dhs) (29), reconstruction nail (31), proximal femoral nail anti-rotation (pfna) (25) and cannulated screws (9).Implants used for the epr group were tumor total hip prostheses consisting of a cementless modular proximal femoral stem and a cementless acetabular cup (beijing chunlizhengda medical instruments co., ltd.Beijing, china) (22,), a cemented allograft-prosthesis composite (depuy solution, warsaw, in, usa) (32), and total hip prostheses consisting of a cementless acetabular cup and a femoral stem (pinnacle cup, corail stem; depuy synthes, usa) (2).The average follow-up duration was 66 months (range 32¿84 months).The article did not specify which of the devices were being used to capture the following complications: 6 patients had local recurrence.2 patients were treated with epr.4 patients underwent a joint-sparing procedure that involved enlarging the curettage and replacing the if.17 patients had complications.8 patients experienced superficial infection and were treated by dressing until the wound healed.2 patients exhibited deep infection and were treated by debridement.2 patients with a rin and pfna in the fifth year and the sixth year after surgery, respectively.Had avascular necrosis.They achieved good function after total hip arthroplasty.1 gct patient had post-operative refracture which was treated with extended resection and revision of the cementless modular proximal femoral stem.4 patients had failure of the internal fixation which was corrected by adjusting the location of the if.This report is for an unknown synthes proximal femoral nail anti-rotation (pfna).It captures the reported events of 6 patients who had local recurrence, 2 patients who were treated with epr, 4 patients who underwent a joint-sparing procedure that involved enlarging the curettage and replacing the if, 17 patients who had complications, 8 patients who experienced superficial infection and were treated by dressing until the wound healed, 2 patients who exhibited deep infection and were treated by debridement, 2 patients with an rin and pfna at the fifth year and the sixth year after surgery, respectively.Had avascular necrosis and 1 gct patient had post-operative refracture which was treated with extended resection and revision of the cementless modular proximal femoral stem.This is report 4 of 10 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10317719
• MDR Text Key: 204185622
• Report Number: 8030965-2020-05228
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 07/07/2020
• 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): Required Intervention