MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNKNOWN EPOCA SHOULDER ARTHROPLASTY SYSTEM; PROSTHESIS, SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMENTED

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the journal article.This report is for an unknown epoca shoulder arthroplasty system/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between (b)(6) 2008 and (b)(6) 2014.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: al-hourani k.Et al (2018), short-term rates of radiolucency after primary total shoulder arthroplasty using a cementless metal-backed pegged polyethylene glenoid, shoulder and elbow, pages 1-7, (united kingdom).The purpose of this study was to investigate the rate of radiographic periprosthetic lucency associated with the use of an uncemented, pegged, metal-backed polyethylene glenoid component.Between may 2008 and november 2014, 57 patients who underwent total shoulder replacements using an unknown synthes epoca shoulder arthroplasty system were included in the study.36 patients were female with a mean age at surgery of 72 years (range 48¿91).Routine retrospective radiographic assessment of the total shoulder arthroplasty consists of anteroposterior and axillary radiographs day 1 post-operatively, then at 6 weeks, 6 months, 1 year and annually thereafter.Prior to inclusion in the study.All patients had 2 main criteria assessed radiographically.Immediate post-operative radiographs were assessed for the completeness of glenoid seating on the subchondral bone, using an a¿e grading system as initially described by lazarus et al.All subsequent interval radiographs were assessed for radiolucency at the bone¿component interface.The mean follow-up was 2.5 years.Complications were reported as follows: 3 patients had radiographs showing radiolucent periprosthetic lines.This report is for an unknown synthes epoca shoulder arthroplasty system.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNKNOWN EPOCA SHOULDER ARTHROPLASTY SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-,HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8717303
• MDR Text Key: 148625502
• Report Number: 8030965-2019-65514
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 06/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention