MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102453507

Device Problem Fitting Problem (2183)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: (b)(4), lot number hj7564; device history batch: null.Device history review: review of device history records finds no related manufacturing deviations or anomalies on the reported lot number ((hj7564).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Der states that the surgeon had struggles with implanting the original poly.He removed some additional soft tissues that may be causing the issue and continued to try to insert the poly.He asked for a second poly when the original had gotten beat up a little in the implant process.The second poly seemed to snap in with no problems at all.The surgeon was pleased with the final product and began the closing process.Doe: (b)(6) 2018; left knee.

• Brand Name: SIGMA HP UNI INS SZ5 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7457549
• MDR Text Key: 106395576
• Report Number: 1818910-2018-58177
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002635
• UDI-Public: 10603295002635
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070267
• 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
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102453507
• Device Lot Number: HJ7564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1