MAUDE Adverse Event Report: DEPUY IRELAND 9616671 LCS COMPLETE M/B PAT CEM LG; KNEE PATELLAR COMPONENT

Catalog Number 129409760

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Clinical der states patient was revised to address femoral loosening at the cement/implant interface.Depuy cement was used.Update rec'd 12/02/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.The medical records indicate the patient was experiencing pain with weightbearing and slightly increased sensitivity to nickel.The patient's tibial component and patella are being added to the complaint and reported.The complaint was updated on: 12/16/2015.

Manufacturer Narrative

No device associated with this report was received for examination.The received medical records were reviewed by a depuy medical professional.From a medical perspective, based on the information available in the received medical records, it is not possible to determine if the complaint is product related.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: LCS COMPLETE M/B PAT CEM LG
• Type of Device: KNEE PATELLAR COMPONENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5303907
• MDR Text Key: 33683984
• Report Number: 1818910-2015-37622
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2015
• Device Catalogue Number: 129409760
• Device Lot Number: 3102135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 107