MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 GLOBAL UNITE HEAD 44X21 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110044620
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Total shoulder replacement, dr.(b)(6); (b)(6), (b)(6) 2018.Initial procedure took place approximately 3 years ago.Patient has since complained of painful shoulder.Surgeon tried to treat conservatively but pain consisted.Took xray of shoulder and determined that the implanted humeral head was too large and could be "over stuffing" the shoulder.During revision surgery the surgeon did indicate that he found the inferior aspect of the anchor peg glenoid component to be loose which could also have contributed to the pain the patient was suffering.The surgeon revised the anatomic tsr to a reverse delta xtend.Female patient initials (b)(6), aged (b)(6) years, dob: (b)(6).
Event or Problem Description
It was reported that the loosening interface is between anchor peg glenoid implant and the glenoid bone is where the surgeon determined it was loose.The affected side was on the left side.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 will be filed as appropriate.

• Brand Name: GLOBAL UNITE HEAD 44X21 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7685009
• Report Number: 1818910-2018-64373
• Device Sequence Number: 10951765
• Product Code: HSD
• UDI-Device Identifier: 10603295004561
• UDI-Public: 10603295004561
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: 110044620
• Device Lot Number: 513024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 07/22/2018; 09/07/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/10/2018
• 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: 72 YR