MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problem Use of Device Problem (1670)

Patient Problems Ossification (1428); Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).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

In the article ¿reverse shoulder arthroplasty in 41 patients with cuff tear arthroplasty with a mean follow-up period of 5 years¿ by nawfal al-hadithy, mrcs; peter domos, mrcs; mathew d.Sewell, frcs; ravi pandit, frcs; published in the journal of shoulder and elbow surgery, in 2014, was reviewed.The purpose of article was producing a study with midterm clinical and radiologic results after reverse shoulder arthroplasty with a mean follow-up of five years due to there being limited studies with midterm and radiologic results.All procedures were done with the delta iii (depuy) but the same surgeon at the same hospital.There were 37 patients with rsa done between 2002 and 2010.There were four complications in the article.Two patients had post-traumatic glenoid failure.One patient fell 6 weeks postoperatively, causing glenoid component to migrate superiorly.He did undergo revision two months after that.One patient fell five months after surgery and sustained a minimally displaced fracture of the acromion.The shoulder was treated non-operatively.One patient had a broken superior glenoid screw at 18 months after initial surgery without any history of trauma.The patient was monitored, by regular radiographs, but no glenoid loosening or other complications occurred.28 shoulders were also noted to experience scapular notching, two patients had malpositioned screws which were uneventful, and periprosthetic heterotrophic ossification was present in 42% of patients.

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: UNKNOWN SHOULDER LOCKING SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9269879
• MDR Text Key: 218553006
• Report Number: 1818910-2019-113789
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention