MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE POLY PATELLA STD+; KNEE PATELLAR COMPONENT

Catalog Number	129409550
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	08/31/2017
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
The patient was revised to address osteolysis and pain.
Additional Manufacturer Narrative
The complaint states the patient was revised to address osteolysis and pain.A review of complaint databases and manufacturing records did not identify any anomalies.Review of x-rays per wi 7915 did not identify any implant fracture or disassociation.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot 2786889.A review of lot 2786889 did not identify any anomalies.(b)(6) products were manufactured and placed into stock on (b)(6) 2008.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
The patient was revised to address osteolysis and pain.

• Brand Name: LCS COMPLETE POLY PATELLA STD+
• Common Device Name: KNEE PATELLAR COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6903168
• Report Number: 1818910-2017-25612
• Device Sequence Number: 16264213
• Product Code: NJL
• UDI-Device Identifier: 10603295022589
• UDI-Public: 10603295022589
• 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): 08/31/2017

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: 129409550
• Device Lot Number: 2786889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 02/15/2018
• 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: 87 YR