MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 52X15 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number 1100-52-600

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.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.

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

Patient had anatomic total shoulder replacement, with subsequent rotator cuff failure, requiring conversion to reverse shoulder replacement.

• Brand Name: GLOBAL UNITE HEAD 52X15 ECC
• Type of Device: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9714060
• MDR Text Key: 184921532
• Report Number: 1818910-2020-04933
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295004721
• UDI-Public: 10603295004721
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1100-52-600
• Device Catalogue Number: 110052600
• Device Lot Number: 458058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2013
• 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
• Patient Age: 60 YR