MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; TAP BONE

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

Patient Problem Pain (1994)

Event Date 05/14/2013

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes dynamic hip system (dhs/dcs)/unknown lot number.Without the specific part number, the udi number and 510k 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.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.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, 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

Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article: shin, s.H., yeo, i.And seo, s.W.(2013), can certain benign lesions of the proximal femur be treated without surgery?, clinical orthopaedics and related research, vol 471 (no.10), pages 3319-3325 (korea, south).The aim of this retrospective study is to investigate (1) whether some benign lesions of the proximal femur can be managed safely using a conservative protocol, (2) if observed according to such a protocol, what is the fracture rate of such lesions at this anatomic site, (3) how many of them progress if managed nonoperatively, and (4) how do the symptoms change with time? between january 2008 to december 2011, a total of 112 patients were included in the study.Among these, 97 were treated conservatively while 15 patients were treated surgically.Four patients were treated with prophylactic internal fixation with a dynamic hip screw (dhs, synthes-stratec, oberdorf, switzerland).The following complications were reported as follows: unknown patients experienced hip pain at least once during follow-up.This report is for an unknown synthes dynamic hip system (dhs/dcs).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Relevant testing captured for reporting.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.

• Type of Device: TAP BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8667656
• MDR Text Key: 146966168
• Report Number: 8030965-2019-64863
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention