MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 PROSTALAC STD 105MM STEM SZ1; CUSTOM/SPECIAL IMPLANT

Catalog Number 154101000

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received a prostalac stem in 2013 with a unipolar head.The stem started to subside, and the patient was tested for infection in (b)(6) 2017.The surgeon removed the stem/head and reimplanted another prostalac stem and unipolar head.It was also reported that there was a loosening of the stem at the bone to cement and cement to implant interface, competitor cement was used.

Manufacturer Narrative

No device associated with this report was received for examination.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 will be filed as appropriate.

• Brand Name: PROSTALAC STD 105MM STEM SZ1
• Type of Device: CUSTOM/SPECIAL IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6692643
• MDR Text Key: 79254679
• Report Number: 1818910-2017-20706
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 154101000
• Device Lot Number: 434612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR