MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE

Catalog Number UNK - SCREWS: TRAUMA

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown screws: trauma/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.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary 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.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

This report is being filed after the review of the following journal article: uri, o., bayley, i., and lambert, s.(2014), hip-inspired implant for revision of failed reverse shoulder arthroplasty with severe glenoid bone loss improved clinical outcome in 11 patients at 3-year follow-up, acta orthopaedica, vol.85(2), pages 171-176 (united kingdom) the objectives of this retrospective study was (1) to determine whether revision arthroplasty with the computer-assisted design/computer assisted manufacture (cad/cam) shoulder would alleviate pain and improve shoulder function in patients with failed reverse shoulder arthroplasty (rsa) and severe glenoid deficiency that is not amenable to reconstruction and inverted glenoid re-implantation; and (2) to determine whether the cad/cam hip inspired glenoid shell would enable secure and durable glenoid component fixation in these challenging revisions.There were 17 patients with inverted glenoid implant failure following grammont-type rsa (11 delta iii (depuy); 3 aequalis reverse prosthesis; 2 smr reverse prosthesis; and 1 tess reversed shoulder) who experienced severe pain and limited function related to their shoulder condition.They had not improved with nonoperative treatment over a period of 6¿12 months.The patients were referred between 2007 to 2011.Of these patients, 11 (8 females and 3 males) underwent revision with the cad/cam shoulder.The patients ages ranged from 58 to 84 years (average age-72years).Revision was performed at a mean of 58 (30¿84) months and the patients were followed-up for mean 35 (28¿42) months.Part of the cad/cam shoulder implant are 3.5 mm titanium fixation screws (depuy synthes, (b)(4)) with hemispheric washers that permit variable angle fixation of the shell to the scapula.Revision was performed by impacting the glenoid shell into the ¿neo-fossa¿ to gain provisional stability within the lateral fornix of the scapula and to secure to the scapula into the ¿neo-fossa¿ in a divergent quadruped fashion using 3.5-mm titanium cortical screws into the lateral column of the scapula, scapular spine, base of coracoid, and glenoid body (if this was possible).One patient had early prosthetic dislocation 2 weeks after the revision, which required an open reduction.In conclusion, the authors reported that the cad/cam shoulder offers an alternative solution for the treatment of failed rsa that is not amenable to glenoid reconstruction.Procedure: reverse shoulder arthroplasty (rsa) revision.Patient's information: delta iii (depuy), n=11 - inverted glenoid implant failure, n=11 - severe pain, n=11 - limited function.3.5 mm titanium fixation screws (depuy synthes, (b)(4)), n=1 - early prosthetic dislocation - an (b)(6)-year-old male.Treatment noted: treatment arm for delta iii (depuy) the inverted glenoid implant failure, severe pain, and limited function were primarily treated with nonoperative treatment but failed, revision surgery was subsequently performed.Treatment arm for 3.5 mm titanium fixation screws (depuy synthes, (b)(4)) early prosthetic dislocation was treated with open reduction.This report is for a 3.5 mm titanium fixation screws (depuy synthes, (b)(4)) with hemispheric washers.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.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

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.A1, a2, a3, a4: there are multiple patients all information is provided in the article.D6: implant date is between 2007 to 2011.H6: code 3191 used to capture surgical intervention and medical device removal.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: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9373835
• MDR Text Key: 185672926
• Report Number: 8030965-2019-70565
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

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
• Device Catalogue Number: UNK - SCREWS: TRAUMA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 01/17/2020
• Supplement Dates FDA Received: 11/26/2019; 01/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR