MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SELF CENT HIP 43X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number	103543000
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2018
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
Metal head was loose.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned product finds it to function as expected.No product problem identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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: SELF CENT HIP 43X28 GRY
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7969645
• Report Number: 1818910-2018-72663
• Device Sequence Number: 1255513
• Product Code: KWY
• UDI-Device Identifier: 10603295003335
• UDI-Public: 10603295003335
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K812672
• 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,Followup,Followup
• Report Date (Section B): 10/10/2018

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: 103543000
• Device Lot Number: HN9642
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 12/11/2018; 01/02/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/07/2018; 12/19/2018; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1