MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN TRILOCK STEM 3 STD; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address large pseudo tumor behind cup, inferiority.It was also indicated that the greater trochanter was affected as well and stem was also removed.Trunnion was stained with what appears to be metal debris.

Manufacturer Narrative

The patient was revised to address large pseudo tumor behind cup, inferiority.It was also indicated that the greater trochanter was affected as well and stem was also removed.Trunnion was stained with what appears to be metal debris 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 will be filed as appropriate.

• Brand Name: UNKNOWN TRILOCK STEM 3 STD
• Type of Device: HIP FEMORAL STEM/SLEEVE
• 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: 6735470
• MDR Text Key: 80774248
• Report Number: 1818910-2017-21602
• Device Sequence Number: 1
• Product Code: JDG
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 86 YR