MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR LG+; LCS COMPLETE : KNEE PATELLA

Catalog Number	129409670
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
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
After opening implants for lcs knee surgeon commented on the patella - that the polyethylene articulating surface felt quite loose against the metal back.He has been using lcs for over 14 years and has a lot of experience and had not noticed this issue before.It was a large+ patella and a size we rarely use so the surgeon preferred for another implant to be opened as he wasn't confident that there was not an issue with the patella.A new one was opened and used.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 5.Action taken when event occurred? --> another patella was opened and used.Was procedure successfully completed? yes.Were fragments generated? no.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no,.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint #: (b)(4).Investigation summary: the device was reviewed by the manufacturer, cork and a report was received stating; due to no similar failures found in the dhr review, returned product meeting specification, and no similar complaints within an 18-month period, the complaint cannot be confirmed.No evidence was found indicating product error was a contributing factor.Should further information come available that impacts the findings in this investigation it will be reopened.Root cause undetermined.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.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 LG+
• Common Device Name: LCS COMPLETE : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8726363
• Report Number: 1818910-2019-96528
• Device Sequence Number: 13954119
• Product Code: NJL
• UDI-Device Identifier: 10603295022671
• UDI-Public: 10603295022671
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2019

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: 129409670
• Device Lot Number: 8290037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/18/2019; 01/07/2020
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 06/25/2019; 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR