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

Catalog Number UNK SHOULDER GLENOSPHERE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/06/2013

Event Type  Injury  

Manufacturer Narrative

(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 ¿short and midterm results of reverse shoulder arthroplasty according to the preoperative etiology¿ by mathias wellmann; melena struck; marc frederic pastor; andre gettmann; henning windhagen; and tomas smith, published online in the arch orthopaedic trauma surgery on february 6, 2013 was reviewed.The purpose of the article was to review reverse shoulder arthroplasty to see if the preoperative etiology influences clinical results after rsa.The article reviewed 76 reverse shoulder arthroplasties for cuff tear arthropathy, fracture sequelae and revision arthroplasty.The follow-up consisted of 71 patients and the mean follow-up period was 23 months.All patients were evaluated postoperatively using the constant score and the simple shoulder test.The patients either had the delta xtend (51) or the delta 3.2 (25), depuy, implanted.71 patients were clinically investigated for a follow-up examination.There were postoperative complications in 19 patients.Scapular notching was also noted in 33 patients." (b)(6)-year-old female; loosening of glenoidal components 32 months after surgery due to scapular notching and required one stage revision with replacement of metaglene.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER GLENOSPHERE
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9288774
• MDR Text Key: 184895056
• Report Number: 1818910-2019-114611
• 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: 10/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR