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 Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 12/08/2017

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

Der states that after holding the leg in extension while the cement cured, surgeon confirmed that the required poly was a sz 5, 7mm insert for a metal backed tibia.The component didn't seem to engage into the tibia after a few attempts, so surgeon requested that i open a second poly to implant.Surgery time was extended for 15-20 minutes.Doe: (b)(6) 2017; left hip.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: 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: 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 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7167562
• MDR Text Key: 96484053
• Report Number: 1818910-2018-50331
• 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,Followup
• Report Date: 12/08/2017

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: 102453507
• Device Lot Number: C72010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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
• Patient Age: 64 YR