MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER LOCKING SCREW

Catalog Number UNK SHOULDER LOCKING SCREW

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report pertains to two instances of the same product.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article reviewed, entitled: "six-year experience with the delta iii reverse shoulder prosthesis", by frederico alberto grassi, et al, published in the journal of orthopaedic surgery (2009; 17(2):151-6).The study of 26 patients who received depuy delta iii reverse shoulder arthroplasties, reported one patient died of lung cancer, and two were excluded from analysis after developing debilitating neurological complications unrelated to their shoulder surgery.This left 23 patients remaining for follow-up.Of these, one patient experienced a partial detachment of the lateral deltoid following an anterosuperior approach, during the immediate post-operative period.Another patient experienced a prosthesis dislocation , which, following prompt reduction, did not recur.Neither of these two complications was reported as requiring additional surgery.Two patients experienced loosening of their glenoid baseplate components requiring revision surgery: one rheumatoid arthritis patient at 6 months post-op, with breakage of two baseplate screws; and the other occurred at 5 years post-op, as a result of severe scapular notching, requiring conversion to a hemiarthroplasty, owing to the significant loss of bone stock in the scapular neck.Authors stated that there were no instances of infection, instability, or acromial fracture.No complications were related to patient comorbidities.Each of the patient complications will be addressed in separate complaints.This complaint will address the patient experiencing implant loosening at 5 years post-primary.Radiograph photos provided showed two locking screws, and severe scapular notching (nerot grade 4), with loosening of the metaglene, at five years post-op.The metaglene and two screws will be reported for loosening, and an unknown humeral component will be reported for the scapular notching.

Manufacturer Narrative

Investigation summary: no devices or product details were returned.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: UNKNOWN SHOULDER LOCKING SCREW
• Type of Device: SHOULDER LOCKING SCREW
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7320526
• MDR Text Key: 101733029
• Report Number: 1818910-2018-54691
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER LOCKING SCREW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/03/2018
• 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