MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown epoca glenoid implant.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown epoca glenoid implant.Pma/510(k) number is not available.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, patient underwent revision surgery due to original glenoid implant becoming loose.The epoca head and eccenter were removed with extractor supplied on the removal instrument tray without any problems.Incident occurred intra-operative on (b)(6) 2017 is captured under (b)(4).Concomitant devices reported: epoca head (part# unknown, lot# unknown, quantity 1) , eccenter (part# unknown, lot# unknown, quantity 1).This report is for one (1) unknown epoca glenoid implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

These dates were incorrectly reported as (b)(6) 2017 in initial report (b)(4).The correct date is (b)(6) 2018.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.

Manufacturer Narrative

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.

Manufacturer Narrative

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: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7293819
• MDR Text Key: 100890193
• Report Number: 8030965-2018-51367
• Device Sequence Number: 1
• Product Code: KWT
• 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,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR