MAUDE Adverse Event Report: DEPUY IRELAND 961610 GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110052620
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision tsr, (b)(6) 2018.Patient complaining of 12 months of shoulder pain as well as limited range of movement.The surgeon was happy to do a thorough release and washout of the shoulder and downsize the head from a 52x21 to a 48x15.Surgeon happy with original prosthesis implantation and cited no issues with original prosthesis or with rotator cuff, so no need to reverse procedure.No evidence of infection.Doi: unknown; dor: (b)(6) 2018; unknown shoulder.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL UNITE HEAD 52X21 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 961610 ; loughbeg ringaskiddy; cork ; EI
• MDR Report Key: 7288704
• Report Number: 1818910-2018-53935
• Device Sequence Number: 11180288
• Product Code: KWA
• UDI-Device Identifier: 10603295004745
• UDI-Public: 10603295004745
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110052620
• Device Lot Number: 544315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018; 11/06/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention