MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL AP PC STEM 12 MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	113012200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/11/2018
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
It was reported that the surgeon removed global unite implants due to malpositioned components and worn glenoid.Surgeon choose to implant a reverse shoulder construct.Doi: unknown; dor: (b)(6) 2018; right shoulder.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.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 AP PC STEM 12 MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7756609
• Report Number: 1818910-2018-65876
• Device Sequence Number: 1560650
• Product Code: KWS
• UDI-Device Identifier: 10603295005544
• UDI-Public: 10603295005544
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K063652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/11/2018

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: 113012200
• Device Lot Number: 586118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: 64 YR
• Patient Weight: 105