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 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 patients 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

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, 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8264658
• MDR Text Key: 133693581
• Report Number: 1818910-2019-81633
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• 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 GLENOSPHERE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention