MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI INS SZ4 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102453407

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(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

Hp uni fixed bearing insert did not lock into the tibial tray anteriorly.Replaced the first insert with another insert of the same size.Was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 3-5 minutes, action taken when event occurred? --> replaced first insert with replacement , was procedure successfully completed? --> yes, were fragments generated? --> no, patient status/ outcome / consequences --> no.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA HP UNI INS SZ4 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8523959
• MDR Text Key: 142354028
• Report Number: 1818910-2019-90920
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002581
• UDI-Public: 10603295002581
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102453407
• Device Lot Number: J1976F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR