MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ELITE MODULAR HEAD 22MM -3; OTHER PRODUCTS

Catalog Number	MS962730000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
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
It was reported that the surgeon found the foreign substance like hair in the package before the surgery on (b)(6) 2017.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.
Additional Manufacturer Narrative
Investigation summary = > the reported event has been evaluated and will be monitored.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.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: ELITE MODULAR HEAD 22MM -3
• Common Device Name: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7137797
• Report Number: 1818910-2017-52322
• Device Sequence Number: 902981
• Product Code: JDI
• UDI-Device Identifier: 10603295244059
• UDI-Public: 10603295244059
• Combination Product (Y/N): N
• PMA/510(K) Number: K871867
• 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
• Report Date (Section B): 11/30/2017

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: MS962730000
• Device Lot Number: D16083280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1