MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 GLOBAL AP HUMERAL STEM 14MM; GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	113014000
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
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.
Event or Problem Description
No secondary seal around implant and implant stickers loose in the box.No sterilization evidence attached to inner implant packaging.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary evaluation of the returned device/packaging components did not identify any product contribution to the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot product code (b)(4), lot number 201351 device history review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL AP HUMERAL STEM 14MM
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7905506
• Report Number: 1818910-2018-70331
• Device Sequence Number: 1438031
• Product Code: HSD
• UDI-Device Identifier: 10603295005551
• UDI-Public: 10603295005551
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 113014000
• Device Lot Number: 201351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR