MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN SHOULDER GLENOSPHERE; SHOULDER HUMERAL HEADS

Catalog Number UNK SHOULDER GLENOSPHERE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Not Applicable (3189); 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.Initial reporter: author of literature article.

Event Description

Review of the article titled "establishing the differential indication for anatomical and reversed shoulder endoprostheses in rheumatoid arthritis" was reviewed on 23-aug-2018 or mdr reportability.Forty-four (44) patients was implanted with a delta iii reverse shoulder prosthesis.Reported adverse events/failures: 50% experienced notching (unknown glenosphere), 6.5% experienced subluxation (unknown glenosphere/cup), 11.4 % experienced infection (unknown implants-will add unknown shoulder implant to pc).All affected patients were reported to have been operated on.

Manufacturer Narrative

No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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. .

• Brand Name: UNKNOWN SHOULDER GLENOSPHERE
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7810346
• MDR Text Key: 118031845
• Report Number: 1818910-2018-67560
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention