MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER GLENOID

Catalog Number UNK SHOULDER GLENOID

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

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 ¿treatment of glenoid loosening and bone loss due to osteolysis with bone grafting¿ by wesley p.Phipatanakul, md and tom r.Norris, md, published in the journal of shoulder and elbow surgery, january/february 2006, was reviewed.The article¿s purpose was to report the results of a study to determine whether this procedure can result in pain relief and functional improvement for the patient.The authors also address the following question: does the bone graft incorporate into host bone and, thereby, improve bone stock sufficiently to allow for placement of a revision glenoid component should postoperative pain require a revision? between august 1997 and 2002, 30 shoulders in 30 patients underwent revision of a total shoulder replacement by conversion to a humeral head replacement with glenoid bone grafting by one surgeon for glenoid loosening due to osteolysis.24 were left for analysis.There were various forms of demineralized bone matrix used by various competitors.The diagnosis was glenoid loosening due to osteolysis in 23 cases and traumatic glenoid loosening as a result of a motor vehicle accident in one.There were 22 global (depuy) prosthesis removed which were implanted between 1991 and 1996, the period of hylamer glenoid component (depuy).The other two prosthesis removed were that of a competitor.The article points out that the majority of the cases in this report were hylamer glenoids.Hylamer is a highly crystalline form of polyethylene that was used between 1990 and 1998 in the depuy global shoulder prosthesis.It is not in current use.

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.Depuy synthes considers the investigation closed.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.

• Brand Name: UNKNOWN SHOULDER GLENOID
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9323317
• MDR Text Key: 182626904
• Report Number: 1818910-2019-113406
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention