MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SIGMA STAB GVF INS 4 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158124010
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Tibial insert ref: (b)(4).Size 4x10mm refused to ¿sit in place¿ after several attempts by a very competent consultant orthopaedic surgeon.Delay in surgery approximately 15 mins, new implant opened and inserted without any issues.No potential patient complaint.Reporting hospital request inspection of the contaminated implant and a replacement there of.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 STAB GVF INS 4 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7288405
• Report Number: 1818910-2018-53891
• Device Sequence Number: 13486684
• Product Code: JWH
• UDI-Device Identifier: 10603295064411
• UDI-Public: 10603295064411
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 158124010
• Device Lot Number: D17021482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 02/22/2018; 08/30/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/23/2018; 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1