MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE HEAD 44X18 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Catalog Number	110044610
Medical Device Problem Codes	Connection Problem (2900); Positioning Problem (3009)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
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
Der states that the global ap stem was assembled using the fix 135 neck angle.The surgeon noticed after it was implanted that the head sat proud.It was removed and disassembled.Using the same stem they converted it to a variable angle and the was prepared as per technique but did not match the trial implant.The size 10 stem was replaced with the new stem and used the variable angle again.There was a surgical delay of 20 minutes.Doe: (b)(6) 2018 right shoulder.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned device did not find any evidence of product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 110044610, lot number hj2044.Device history batch: null.Device history review: review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number (hj2044).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 44X18 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7315988
• Report Number: 1818910-2018-54569
• Device Sequence Number: 119729
• Product Code: HSD
• UDI-Device Identifier: 10603295004554
• UDI-Public: 10603295004554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2018

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 Catalogue Number: 110044610
• Device Lot Number: HJ2044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 12/03/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/23/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR