MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ADVANTAGE HUM HD 52X15; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS

Model Number	1128-52-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	05/03/2018
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
Maude report received.It was reported that the patient received a left hemi shoulder arthroplasty with a depuy synthes global advantage system involving a 52mm global advantage cocr humeral head and size 8 global advantage standard stem.On 2017, she experienced sudden and new onset of fatigue, dyspnea, confusion, polyneuropathy, balance issues, headaches, tinnitus, vision and hearing issues, word finding issues, tremor/changes in handwriting, mood changes, and difficulty with multitasking.The humeral stem was revised because depuy did not have a non-cobalt head option.The glenoid had significant posterior erosion but adequate bone remained for resurfacing with the posteriorly augmented cortilock small glenoid.Pathology report of frozen section of left shoulder synovial tissue notable for signs of chronic inflammation including mild to moderate lymphohistiocytic inflammation and dense chronic perivascular lymphocytic inflammation (alval).Cobalt level of left shoulder fluid was 64 mcg/l and chromium level was 78 mcg/l, her blood and urine cobalt levels initially dropped following revision of the left shoulder.Doi: (b)(6) 2015.Dor: (b)(6) 2018.Left shoulder.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: GLOBAL ADVANTAGE HUM HD 52X15
• Common Device Name: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9963425
• Report Number: 1818910-2020-10801
• Device Sequence Number: 10948111
• Product Code: HSD
• UDI-Device Identifier: 10603295005193
• UDI-Public: 10603295005193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: 1128-52-000
• Device Catalogue Number: 112852000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHOULDER HUMERAL STEM
• Outcome Attributed to Adverse Event: Required Intervention