MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 40MM IMPLANT TO TRIAL ADAPTER; HIP INSTRUMENTS : ADAPTORS

Catalog Number	298740040
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.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 will be filed as appropriate.
Event or Problem Description
It was reported that the 40mm trial to real implant segment is not attaching correctly.The trial sits 10-15mm proud.

• Brand Name: 40MM IMPLANT TO TRIAL ADAPTER
• Common Device Name: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8256744
• Report Number: 1818910-2019-81253
• Device Sequence Number: 1915635
• Product Code: LXH
• UDI-Device Identifier: 10603295158752
• UDI-Public: 10603295158752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2018

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: 298740040
• Device Lot Number: B0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1
• Patient Age: 70 YR