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

Catalog Number UNK SHOULDER HUMERAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 # 9(b)(4).Investigation summary
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> 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 90-year old patient due to cardiac insufficiency, a cerebrovascular accident postoperatively in an 86-year old patient and a 68-year old 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
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> null device history batch
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> null device history review
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> null 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.- attachment: [pc-000564064 mirf-000101996 - literature article.Pdf, pc-000564064 guidance form.Xlsx].

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 90-year old patient due to cardiac insufficiency, a cerebrovascular accident postoperatively in an 86-year old patient and a 68-year old 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
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> 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.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• 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 ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9168576
• MDR Text Key: 170184012
• Report Number: 1818910-2019-108142
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 10/02/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/29/2019
• Supplement Dates FDA Received: 11/29/2019
• 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): Hospitalization; Required Intervention