Catalog Number UNK SHOULDER HUMERAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Pulmonary Embolism (1498); Stroke/CVA (1770); Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Joint Dislocation (2374)
|
Event Date 03/17/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint was received into the company in the form of a literature paper with the following comment: the literature article entitled, ¿medium-term results after primary hemiarthroplasty for comminute proximal humerus fractures: a study of 46 patients followed up for an average of 4.4 years¿ by carina m gronhagen, md, hassan abbaszadegan, md, phd, suzanne a.Revay, rpt, and per y.Adolphson, md, phd, stockholm, sweden published by the journal of shoulder and elbow surgery board of trustees, volume 16, issue 6 published in 2007.No products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: the purpose of the article ¿evaluated the functional radiographic results after primary hemiarthroplasty in all severely displaced fractures of the proximal humerus that were treated at danderyd hospital between 1989 and 2002¿.The data was compiled of 82 patients who underwent a primary hemi-arthroplasty after a severely displaced 2-, 3- or 4-part fracture of the proximal humerus between june 1989 and november 2002.All patients were operated on using a deltopectoral approach in a semi sitting position and were done by (1) orthopedic shoulder surgeon operating at danderyd hospital.The tuberosities were reattached to the proximal humerus and the prosthesis by using nonabsorbable sutures.Depuy products utilized in 39 patients, the global prosthesis, all but one, which was press-fitted, were cemented.Of the 39 patients that used depuy products, 17 were followed up with.The other 42 patients received competitor products.The article indicates that superior migration and glenoid erosion were more common in patients with the global prosthesis and all patients with glenoid erosion also had superior migration.The total findings were: 15 had superior migrations, 11 had glenoid erosion, 11 had ectopic bone formation and 4 had a tuberosity displacement.The patients that experienced superior migrations, are reasonable to conclude the result of joint instability as the joint migrated, not the device.Also reported in the article, however not related directly to the product, was the death of a (b)(6) patient due to cardiac insufficiency, a cerebrovascular accident postoperatively in an (b)(6) patient and a (b)(6) patient that had a transient ischemic attack.Another patient had a postoperative dislocation and was treated with an open reduction and reattachment of the subscapularis tendon and the greater tuberosity to the prosthetic head 42 days postoperatively.Only one patient contracted a superficial wound infection, which required debridement 45 days postoperatively and suffered a pulmonary embolism without further complications.Without returned parts, no further investigation of the associated products can be made.No investigation as to manufacturing defects can be made without product codes and batch numbers.Post-market surveillance is per sep-419.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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: null.Device history batch: null.Device history review: null.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
|
The literature article entitled, ¿medium-term results after primary hemiarthroplasty for comminute proximal humerus fractures: a study of 46 patients followed up for an average of 4.4 years¿ by carina m gronhagen, md, hassan abbaszadegan, md, phd, suzanne a.Revay, rpt, and per y.Adolphson, md, phd, stockholm, sweden published by the journal of shoulder and elbow surgery board of trustees, volume 16, issue 6 published in 2007, was reviewed for mdr reportability.The purpose of the article ¿evaluated the functional radiographic results after primary hemiarthroplasty in all severely displaced fractures of the proximal humerus that were treated at danderyd hospital between 1989 and 2002¿.The data was compiled of 82 patients who underwent a primary hemi-arthroplasty after a severely displaced 2-, 3- or 4-part fracture of the proximal humerus between june 1989 and november 2002.All patients were operated on using a deltopectoral approach in a semi sitting position and were done by (1) orthopedic shoulder surgeon operating at danderyd hospital.The tuberosities were reattached to the proximal humerus and the prosthesis by using nonabsorbable sutures.Depuy products utilized in 39 patients, the global prosthesis, all but one, which was press-fitted, were cemented.Of the 39 patients that used depuy products, 17 were followed up with.The other 42 patients received competitor products.The article indicates that superior migration and glenoid erosion were more common in patients with the global prosthesis and all patients with glenoid erosion also had superior migration.The total findings were: 15 had superior migrations, 11 had glenoid erosion, 11 had ectopic bone formation and 4 had a tuberosity displacement.The patients that experienced superior migrations, are reasonable to conclude the result of joint instability as the joint migrated, not the device.Also reported in the article, however not related directly to the product, was the death of a (b)(6) patient due to cardiac insufficiency, a cerebrovascular accident postoperatively in an (b)(6) patient and a (b)(6) patient that had a transient ischemic attack.Another patient had a postoperative dislocation and was treated with an open reduction and reattachment of the subscapularis tendon and the greater tuberosity to the prosthetic head 42 days postoperatively.Only one patient contracted a superficial wound infection, which required debridement 45 days postoperatively and suffered a pulmonary embolism without further complications.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.
|
|
Search Alerts/Recalls
|
|