MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL BODY

Catalog Number UNK SHOULDER HUMERAL BODY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

An article, entitled: ¿short-term outcomes of the grammont reverse shoulder arthroplasty: comparison between first and second generation delta prosthesis¿, by riccardo luigi alberio, marco landrino, paolo fornara, and federico alberto grassi, published in joints 2019;7:141¿147, was reviewed.The authors reported on a short term retrospective review of 1st and 2nd generation grammont-type depuy reverse total shoulder arthroplasties, the delta 3 (group d-3) and the delta xtend (group d-xt), to compare outcomes between the two generations of prothesis.Twenty-three patients from group d-3 were available for follow-up at 5 years; one patient died of lung cancer and two patients could not be evaluated due to debilitating neurological conditions unrelated to their surgery.Twenty-two patients (for a total of 24 implants) from group d-xt were evaluated; three patients died from causes unrelated to the surgical procedure, and two patients were hospitalized in geriatric facilities for cognitive impairment, and unavailable.Early complications observed in group d-3: one partial detachment of the lateral deltoid after trans-deltoid approach, that was treated conservatively and healed uneventfully, and one shoulder dislocation, that was reduced and did not recur.Early complications observed in group d-xt: an early deep infection occurred in one patient 2 weeks after surgery: it was treated with debridement, glenosphere, and humeral insert replacement and 6-week targeted antibiotic therapy.At 4-year follow-up, there were no signs of infection, but the patient complained of recurrent shoulder discomfort and radiographs showed progressive humeral radiolucency combined with scapular notching.Late complications: two cases of glenoid construct loosening occurred in group d-3, at 6 months and 5 years, with both patients undergoing revision surgery.The first had the glenoid construct replaced using a special metaglene with a plate, for additional screw fixation, and cancellous bone graft to fill the bone defect at the scapular neck.The second was treated with conversion to a hemiarthroplasty due to the extensive bone loss and low functional demands.No late complications were observed in group d-xt.Radiographically, it was observed that the incidence, severity, and progression of scapular notching was higher in group d-3 versus d-xt, with 100% of d3 showing evidence, while only 22.2% of group d-xt demonstrated notching.Humeral radiolucencies were observed in three patients in d3, and one in group d-xt.Heterotopic ossification was observed radiographically in 4 patients from group d-3, and 3 from group d-xt.No treatments were reported to address the radiographic findings.Functional surveys, while generally showing marked improvements across all indicators, still had some patients reporting poor shoulder function and pain at 5 years.Patients in study were not identified by specific case or age/gender identifiers.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed.The x-rays available in the literature article cannot confirm the event reported.There is not enough evidence related to the event.Therefore, there is not sufficient information related to the reported event and no result can be obtained from it.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: UNKNOWN SHOULDER HUMERAL BODY
• Type of Device: SHOULDER HUMERAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12421504
• MDR Text Key: 269770637
• Report Number: 1818910-2021-19297
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL BODY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention