MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL C.A.P. HEAD HA 52X18; GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS

Model Number 1230-52-015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/04/2020

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.

Event Description

The patient was revised due to grossly deficient rotator cuff.Converted to a reverse total shoulder arthroplasty.Doi: unknown, dor: (b)(6) 2020, left shoulder.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL C.A.P. HEAD HA 52X18
• Type of Device: GLOBAL CAP IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10895543
• MDR Text Key: 217989511
• Report Number: 1818910-2020-25192
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295017813
• UDI-Public: 10603295017813
• Combination Product (y/n): N
• PMA/PMN Number: K033516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1230-52-015
• Device Catalogue Number: 123052015
• Device Lot Number: AB9FC1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR