MAUDE Adverse Event Report: DEPUY IRELAND 9616671 LCS COMPLETE M/B PAT POR STD; PATELLA IMPLANT

Catalog Number	129409640
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/02/2017
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
This patient had original surgery approx 12 months ago and was admitted to hospital a few days ago with severe pain and was unable to weight bare.No evidence of infection intra-operatively or in bloods.Dr took multiple specimens.Images available show no in growth on any of the implants removed.All components were loose - femoral component removed by hand and replaced with cemented revision components.
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 will be filed as appropriate.

• Brand Name: LCS COMPLETE M/B PAT POR STD
• Common Device Name: PATELLA IMPLANT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7075344
• Report Number: 1818910-2017-50582
• Device Sequence Number: 926902
• Product Code: NJL
• UDI-Device Identifier: 10603295022640
• UDI-Public: 10603295022640
• 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: 2016
• 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): 11/02/2017

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: 129409640
• Device Lot Number: 8272409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 08/03/2018
• 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: 73 YR