MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA HP UNI INS SZ5 7MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102454507

Device Problem Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 07/23/2018

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

It was reported that the poly would not seat into the tibial tray and appeared to be defective.Doi: unknown; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary examination of the returned device revealed evidence confirming the reported event.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.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 SZ5 7MM RM/LL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7788455
• MDR Text Key: 117273325
• Report Number: 1818910-2018-66817
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002932
• UDI-Public: 10603295002932
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102454507
• Device Lot Number: H11631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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