MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC STEM TRIAL EXTRACT; KNEE INSTRUMENT/TRIAL

Catalog Number 865226

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/10/2017

Event Type  malfunction  

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

It was reported that while trying to remove the femoral sleeve trial and trial stem, the trial stem extractor would not thread into the trial stem.We had another one in hand and used that fine.When we examined the first stem extractor, the tip where the threads are was noted to be bent.Apparently bent enough that it wouldn't let the doctor thread it into the trial stem.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Additional narrative: examination of the returned device confirmed the reported event.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: PFC STEM TRIAL EXTRACT
• Type of Device: KNEE INSTRUMENT/TRIAL
• 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: 6852544
• MDR Text Key: 85433226
• Report Number: 1818910-2017-24373
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295216766
• UDI-Public: 10603295216766
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 865226
• Device Lot Number: G1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 08/30/2017; 09/28/2017
• Supplement Dates FDA Received: 09/11/2017; 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2004
• 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 Age: 60 YR