MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL UNITE HEAD 40X15 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110040600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	06/29/2018
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.Concomitant med products: unknown shoulder glenoid; unknown shoulder humeral stem; unknown bone cement.
Event or Problem Description
The patient was revised to address pain and range of motion issues.Surgeon removed osteophytes and changed head from eccentric to standard.Doi: (b)(6) 2018; dor: (b)(6) 2018; right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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 UNITE HEAD 40X15 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7723055
• Report Number: 1818910-2018-65300
• Device Sequence Number: 19220867
• Product Code: HSD
• UDI-Device Identifier: 10603295004493
• UDI-Public: 10603295004493
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 110040600
• Device Lot Number: 398957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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: .
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR