MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE HUM HD 52X18; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Model Number 1128-52-010

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

Patient Problems Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 to address tightness of the shoulder and lack of rom.Doi: unknown, dor: (b)(6) 2020, right shoulder.

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.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.

• Brand Name: GLOBAL ADVANTAGE HUM HD 52X18
• Type of Device: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10390782
• MDR Text Key: 202372796
• Report Number: 1818910-2020-17851
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295005209
• UDI-Public: 10603295005209
• Combination Product (y/n): N
• PMA/PMN Number: K984541
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1128-52-010
• Device Catalogue Number: 112852010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention