MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG MOD TIB TRAY CEM COCR 1.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158115000
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Aseptic loosening of a tibia implanted in 2016, on removal on the tray the plastic screw at the bottom of the tibia was cracked in multiple places.Mr (b)(6) has never seen this before and wonders if this may have a relation to the loosening of the tibial tray and also has wondered what has caused this to crack inside the patient.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIG MOD TIB TRAY CEM COCR 1.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7321045
• Report Number: 1818910-2018-54697
• Device Sequence Number: 18857964
• Product Code: JWH
• UDI-Device Identifier: 10603295063568
• UDI-Public: 10603295063568
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158115000
• Device Lot Number: 3590993
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/05/2018; 09/10/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 03/09/2018; 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other