MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL CUP; SHOULDER IMPLANT

Catalog Number UNK SHOULDER HUMERAL CUP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Neurological Deficit/Dysfunction (1982); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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 will be filed as appropriate.9 patient involved.

Event Description

Update 14-jan-2018: "reverse shoulder arthroplasty for the treatment of three- and four-part fractures of the proximal humerus in the elderly" was read for mdr reportability.After review of the article for mdr reportability, the article indicates a delta reverse shoulder was implanted in 43 patients between january 2000 to january 2005.No patient identifies were provided for the 43 patients.Of the 43 patients the following patient harms and product deficiencies were noted: five patients experienced neurological complications which mostly resolved; three patients experienced reflex sympathetic dystrophy which resolved; one patient experienced a non-traumatic dislocation 6 weeks after implantation.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL CUP
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8264641
• MDR Text Key: 133700129
• Report Number: 1818910-2019-81632
• Device Sequence Number: 1
• Product Code: KWS
• 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: 01/14/2019

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 CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention