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

Catalog Number UNK SHOULDER HUMERAL CUP

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

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 number 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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised due to dislocated shoulder.Doi: (b)(6) 2020, dor: (b)(6) 2020, right shoulder.

• Brand Name: UNKNOWN SHOULDER HUMERAL CUP
• Type of Device: SHOULDER HUMERAL CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10868887
• MDR Text Key: 217145714
• Report Number: 1818910-2020-25002
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2020

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 HUMERAL CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/19/2020
• 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
• Treatment: 38 STD GLENOSPHERE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR