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

Catalog Number	110052500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	08/31/2018
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
Left humeral hemi-arthroplasty, dr (b)(6), (b)(6) hospital (b)(6) 2018.Primary implantation - left shoulder hemi-arthroplasty about 2 years ago in (b)(6) by dr.(b)(6).The shoulder was infected and some tests were done and dr.(b)(6) found out that the patient had a pseudomonas infection in his left shoulder.The skin was red, slightly edematous and inflamed.After skin incision, it was immediately noticeable that there was pus coming out.Multiple swabs and culture specimen were taken while dr.(b)(6) opened up into the joint.Once in the shoulder joint, dr.(b)(6) used the tuning fork to remove the humeral head and the suture collar, and then he used the big vice grip forceps and slap hammer to take the stem and proximal body out.He put in a zimmer spacer with antiobiotic cement, compounded by some more antibiotic and closed up the joint.His plan is to remove the spacer once the infection has subsided and to put a delta xtend in.Male patient initials (b)(6), aged (b)(6) years old, dob: (b)(6).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was received.The complaint was due to infection.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 will be filed as appropriate.

• Brand Name: GLOBAL UNITE HEAD 52X15 STD
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7905345
• Report Number: 1818910-2018-70298
• Device Sequence Number: 13837798
• Product Code: HSD
• UDI-Device Identifier: 10603295004691
• UDI-Public: 10603295004691
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170748
• 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
• Report Date (Section B): 08/31/2018

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: No Information
• Device Catalogue Number: 110052500
• Device Lot Number: 202469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR