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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown epoca.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.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jonas, sc., walton, mj and sarangi, pp.(2011), management of a periprosthetic fracture after humeral head resurfacing total shoulder replacement: a case report, journal of shoulder and elbow surgery, vol.20(5), pages e18-e21 ((b)(6)).This study presents a case report of the management and 1-year follow-up of a (b)(6) woman undergone a successful contralateral resurfacing total shoulder arthroplasty (tsa).The prosthesis used in both cases was the epoca humeral head resurfacing and hybrid glenoid replacement (synthes, (b)(4)).She fell in her home, 2 weeks after her procedure, sustaining a periprosthetic fracture.Radiographs demonstrated a fracture at the surgical neck of the proximal humerus (fig.1).The fracture was initially minimally displaced, and a trial of conservative treatment, with a collar and cuff, was attempted.Subsequent radiographs, however, demonstrated significant displacement (fig.2), and a decision was therefore made to manage the fracture surgically or reoperation was performed to fix the fracture.The fracture was openly reduced and internally fixed using a precontoured anatomic proximal humeral internal locking system (philos) locking plate (synthes; figs.3 and 4).At 1 year, the patient still has some activity-related discomfort but is able to actively abduct her shoulder to 130° and externally rotate to 60°.This is equivalent to the contralateral side, which also has had a resurfacing tsa.Radiographs at this time show a well-fixed fracture and a well-positioned shoulder replacement (fig.5).This report is for an unknown epoca.This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: PROSTHESIS,SHOULDER,NONCONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8218665
• MDR Text Key: 132203038
• Report Number: 8030965-2019-59456
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• 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: 68 YR