MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RP INSERT STD+ 15MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405515
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
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
Revision total knee replacement.Dr (b)(6), (b)(6) on (b)(6) 2017.Patient underwent primary tkr (b)(6) 2009 (dr (b)(6), (b)(6)).Patient presented at 6 month follow up with a somewhat stiff knee.Patient has then disappeared from follow up and has presented recently with a painful and stiff knee, with a range of motion of 15-45 degrees.A decision was made to revise the knee.On opening the knee, the components were well fixed.Radial scratches were evident on the tibial tray, once the insert had been removed.The posterior capsule was released along with the mobilisation of the medial and lateral gutters.All components were removed and a pfc tc3 rp implanted (with sleeves and stems) the knee was able to fully extend and passively flex to approximately 115 degrees.Male patient initials (b)(6), aged (b)(6), dob (b)(6).Doi: (b)(6) 2009; dor: (b)(6) 2017; unknown knee.
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.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: LCS COMP RP INSERT STD+ 15MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7160191
• Report Number: 1818910-2018-50114
• Device Sequence Number: 16495721
• Product Code: NJL
• UDI-Device Identifier: 10603295022107
• UDI-Public: 10603295022107
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 129405515
• Device Lot Number: C2SAN4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 08/07/2018
• 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: Required Intervention
• Patient Age: 77 YR