MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 44X15 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110044600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 of shoulder arthroplasty ; dr.(b)(6); (b)(6) hospital (b)(6) 2018.Primary implant date (b)(6) 2017.Patient complained of pain and mild instability, 6 months history.Synovectomy, and change of humeral head carried out.40 x 15mm eccentric head implanted.Both humeral stem and glenoid apg+ components were solidly still fixed, left issue.Multiple specimens taken.Patient outcome post surgery: stable shoulder joint.Female patient initials lt, dob: (b)(6).X-rays uploaded to unity.
Additional Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 44X15 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7629128
• Report Number: 1818910-2018-62919
• Device Sequence Number: 1638212
• Product Code: HSD
• UDI-Device Identifier: 10603295004547
• UDI-Public: 10603295004547
• 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 Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 110044600
• Device Lot Number: C87132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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
• Patient Age: 55 YR