MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - EPOCA; PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Event date unknown.This report is for an unknown epoca/unknown lot.Part and lot numbers are unknown; udi 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.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.(b)(4).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: page rs, et al.(2018), cementless versus cemented glenoid components in conventional total shoulder joint arthroplasty: analysis from the australian orthopaedic association national joint replacement registry, journal of shoulder and elbow surgery, volume 27, page 1859-1865, (australia).The study aim was to compare the revision rate between cemented and cementless design glenoid components in conventional total shoulder arthroplasty performed for osteoarthritis.Between april 16, 2004, and december 31, 2016, all conventional primary total shoulder arthroplasty procedures reported to the australian orthopaedic association national joint replacement registry were analyzed for revision (exchange of a component).Within the study period, 10,805 primary conventional total shoulder arthroplasties were identified.The majority of conventional total shoulder arthroplasties were in female patients.The median age was 71 years for female patients and 67 years for male patients.An unknown synthes epoca shoulder arthroplasty system was used in a total of 50 cases while the rest of the cases were implanted with varying competitors' devices.Complications were reported as follows: 3 cases were revised.Diagnoses of these revisions were not specified.However, the article mentions the following revision diagnoses for the cemented implants: rotator cuff insufficiency.Instability and/or dislocation.Loosening.Implant breakage of glenoid.Fracture.Pain.Incorrect sizing.Arthrofibrosis.Malposition.Lysis.Glenoid erosion.Implant breakage of humeral component.This report is for the unknown synthes epoca shoulder arthroplasty system.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - EPOCA
• Type of Device: PROSTHESIS,SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMEMTED
• 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: 9977596
• MDR Text Key: 194010021
• Report Number: 8030965-2020-02936
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2020
• 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