MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CMNT: TRAUMACEM; FILLER, BONE VOID, CALCIUM COMPOUND

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - biomaterial - cement: traumacem/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Investigation summary: 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.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from synthes reports an event in argentina as follows: this report is being filed after the review of the following journal article: llano, l.Et al.(2019), cement leakage into the hip joint during tfn-a cement augmentation in a revision surgery of an extra-capsular hip fracture, trauma case reports, vol.22, pages 1-6 (argentina) this study presents a case report of an (b)(6)-year-old male patient who had an externally rotated, abducted and shortened leg with severe pain on his left hip due to a low energy fall.Close reduction and internal fixation were performed.After 3 months of being discharged, he complained of severe hip pain and impossibility for weight bearing.Radiographs and a ct-scan were indicated.Intra-articular cephalic spiral lamina migration was evidenced.A revision surgery was planned, including the spiral lamina replacement and cement augmentation due to poor bone stock quality.A polypropylene mesh was introduced into the femoral head to prevent cement leakage.Hip joint surface integrity was reassured through contrast injection and intraoperative radioscopic control.After cephalic spiral lamina revision and during augmentation, a cement leakage was observed and contrasted with the injected radiopaque solution.In the immediate postoperative radiographic control, the presence of intraarticular cement was confirmed.A new intervention was indicated, and a posterolateral approach was performed, followed by a meticulous capsulotomy of the joint and direct observation of the migrated material.The foreign body was in intimal contact with the hip loading area and was successfully extracted.As a consequence, an additional osteochondral lesion of the femoral head was also identified without other associated labral or acetabulum lesions.Finally, profuse irrigation and meticulous closure of the joint capsule was performed.This report is for an unknown synthes tfna and cement.This is report for 02 of 02 of (b)(4).

• Brand Name: UNK - BIOMATERIAL - CMNT: TRAUMACEM
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9205416
• MDR Text Key: 166529019
• Report Number: 8030965-2019-69438
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• 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): Required Intervention
• Patient Age: 83 YR