MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ0/1 HI NECK SEGMENT; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	257003050
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
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
The materials presented oxidation.(b)(6).D257003150 neck 2/3 hi lot mt47132, d258003400 neck 8/9 st lot mt447377, d2577003050 neck 0/1 hi lot mt40595, d267003200 neck 4/5 st lot mt47047, d257003300 neck st 6/7 lot mt47294, d24400549 strawberry 49 lot s02019713, d24400542 strawberry 42 lot s02015959.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summarythe instrument associated with this report was not returned.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: SUMMIT SZ0/1 HI NECK SEGMENT
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7663602
• Report Number: 1818910-2018-63790
• Device Sequence Number: 14082094
• Product Code: LXH
• UDI-Device Identifier: 10603295143062
• UDI-Public: 10603295143062
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 257003050
• Device Lot Number: MT40595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1