MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK STEM TRIAL

Catalog Number UNK STEM TRIAL

Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189); No Code Available (3191)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 the patient was having a left total knee revision.The surgeon did all the proper prepping for a stem and sleeve for the femur.The surgeon over reamed 1 mm, and broached properly.The trial construct sat perfectly.During impaction of the real femoral component, the patient's femur cracked/broke.The implant was fully seated by the surgeon, and the surgeon put 2 cables around the femur to stabilize the fracture.The press fit between the trial broach and stem compared the real implant is too much.This causes fractures and endangers the patient.There was a surgical delay of 15 mins doe: (b)(6) 2020, left knee.

Manufacturer Narrative

Product complaint #
=
> (b)(4) investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: h6 (patient and device codes) h6 patient code: no code available (3191) used to capture the surgery prolonged.

• Brand Name: UNK STEM TRIAL
• Type of Device: UNK STEM TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10130794
• MDR Text Key: 194941362
• Report Number: 1818910-2020-13404
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK STEM TRIAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 4 MM; ATTUNE DIST FEM AUG SZ 8 4 MM; ATTUNE POS FEM AUG SZ 8 8 MM; ATTUNE POS FEM AUG SZ 8 8 MM; ATUN FEM SLV M/L 50 MM FULL POR; ATUNE PRESSFIT STR STEM22X60 MM
• Patient Age: 73 YR