MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG MOD TIB TRAY CEM COCR 1.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158115000
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
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
Failure to properly seat 30mm stem extension implant to sigma fixed bearing tibial tray.Surgical tech could not fully seat threaded stem extension implant to tibial tray cone even when applying significant mechanical torque force.Under normal circumstances the stem extension implant can be mostly seated to the tibial implant by hand resulting in the need only to slightly torque to appropriate tension using the stem wrench instrument.In this case the tech was not able to fully seat with significant effort.Surgeon then requested to have another (additional same sized stem implant) opened with a similar end result.He then attempted to further torque under his own strength and was finally able to seat the stem to a point appearing to be flush with the threaded tibial cone implant.The consensus was that perhaps there was a defect in the thread pattern of the receiving tibial tray implant and that through significant torque force the harder tibial tray threads perhaps cross threaded the softer metal stem threads resulting in full or nearly full seating of the two pieces.Both opened stem extension implants were subsequently wasted due to circumstances unrelated to the difficulty of seating the stem to tray.Note: my concern is that perhaps there may be a manufacturing defect in the thread pattern for the specific lot number associated with the tibial tray implant ref #(b)(4) lot 8742929.This ref# was on backorder for a significant amount of time therefore i am concerned that there may have been an associated quality control issue with this lot number.Due to the frequency of use in my territory of this construct i remain concerned about any potential on going issues.Patient consequence? :yes patient consequence description:delay in final implantation of approximately 10 minutes is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: product code 158115000, lot number 8742929 device history review: dhr review product code: 158115000, work order (b)(4) was manufactured on (b)(4) 2018.12 parts were manufactured per specification and all raw materials met specification.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 # pc-(b)(4).Investigation summary no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot product code (b)(4), lot number 8742929 product code (b)(4), work order (b)(4) was manufactured on (b)(4) 2018.12 parts were manufactured per specification and all raw materials met specification.If information is obtained that was not available for the initial medwatch , a follow-up 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7424626
• Report Number: 1818910-2018-57177
• Device Sequence Number: 147456
• Product Code: JWH
• UDI-Device Identifier: 10603295063568
• UDI-Public: 10603295063568
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K032151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 158115000
• Device Lot Number: 8742929
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 09/17/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/19/2018; 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR