MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMPLETE REV FEM CEM R STD; LCS REVISION : KNEE FEMORAL

Catalog Number	129428040
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 unpacking a sterile lcs vvc femur, we discovered an unknown contamination on the prosthesis.It was hard and dry when touching it, so definitively no tissues from the surgery.As we only had this size of prosthesis once in the hospital, the doctor carefully cleaned this contamination manually and rinsed the prosthesis with lavasept before implanting it.
Additional Manufacturer Narrative
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.H10 additional narrative: product complaint # : (b)(4).Investigation summary : a review of the returned photograph identified the contaminant as pyro-clean used to de-pyrogenate product.It is used on the cleaning/ passivation process in the atm lines at final clean and pack.This cleaning aid was changed to proklenz approximately twelve months ago because of issues with it leaving a white residue, similar to this case.The complaint was found to be justified and shall be closed with a root cause of device manufacturing.As the substance is no longer used, no further corrective action needs to take place.Device history lot : null device history batch : null device history review : null 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 COMPLETE REV FEM CEM R STD
• Common Device Name: LCS REVISION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8627981
• Report Number: 1818910-2019-94160
• Device Sequence Number: 16708696
• Product Code: NJL
• UDI-Device Identifier: 10603295025450
• UDI-Public: 10603295025450
• Combination Product (Y/N): N
• PMA/510(K) Number: P830055
• 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
• Report Date (Section B): 05/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129428040
• Device Lot Number: HT7873
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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