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

Catalog Number UNK SHOULDER HUMERAL HEAD

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

Patient Problem Hematoma (1884)

Event Date 01/01/2006

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.(b)(4).

Event Description

The literature article entitled ¿augmented subscapularis muscle transposition for rotator cuff repair during shoulder arthroplasty in patients with rheumatoid arthritis¿ by nobuyuki tanaka, md; hisashi sakahashi, md; kazuya hirose, md; and seiichi ishii, md; published in the journal of shoulder and elbow surgery, volume 15, number 1, january/february 2006, was reviewed.The articles purpose was to report on the clinical study performed to evaluate the results of the repaired cuffs by (1) augmented subscapularis transposition and (2) subscapularis transposition alone in comparison with the results of intact rotator cuffs in ra patients with total shoulder arthroplasty.Between 1993 and 2000, global total shoulder arthroplasties were implanted in patients with ra.The status of the rotator cuff was assessed at the time of the arthroplasty.Significant cuff tearing was present in 52 shoulders, 13 of them underwent direct suture for repair of the ruptured cuff.In the other 39, subscapularis transposition into the defect in the supraspinatus tendon or in the supraspinatus and infraspinatus tendons was performed.All shoulder arthroplasty¿s were performed by the same surgeon using a deltopectoral approach.Humeral components were cemented and keeled glenoid components were placed with cement.The patients were divided into three groups; a, b and c.None of the patients underwent revision during the follow-up.Lucency around the humeral component in 1 zone, lucency around the glenoid component in 1 zone and superior migration of the humeral head by more than 5 mm were seen in 0%, 40%, and 5.0% of shoulders in group a, after a follow-up of one year and in 5.0%, 80% and 15% of shoulders in group a, respectively, after a follow-up period of two years or longer.Lucency around the humeral component in 1 zone, lucency around the glenoid component in 1 zone and superior migration of the humeral head by more than 5 mm were seen in 5.3%, 47% and 11% of shoulders in group b, after a follow-up of one year and in 11%, 84% and 21% of shoulders in group b of patients after a follow-up of two years or longer, 11% of shoulders in group b had lucency around the glenoid component in 3 zones.Lucency around the humeral component in 1 zone, lucency around the glenoid component in 1 zone and superior migration of the humeral head by more than 5 mm were seen in shoulders of group c at one year and two years or longer after the operation had the same tendency as those of shoulders in group a.The incidence of readiolucency of glenoid components after a follow-up period of 2 years or longer in groups a and c was significantly lower than that in group b.No complications occurred in groups a and c.One patient in group b had infected hematoma requiring debridement 2 weeks postoperatively.It should be noted that the patients in this study had instability in the rotator cuff muscles due to ra which attributed to "superior migration".All patients underwent some type of repair during the hemiarthroplasty operation.

Manufacturer Narrative

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.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.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 HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9336068
• MDR Text Key: 185046523
• Report Number: 1818910-2019-114696
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention