MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LPS CEMENTED STEM 12X125MM STR; KNEE OTHER IMPLANT

Catalog Number	198725412
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	08/24/2017
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
Patient was revised to address pain, osteolysis and loosening of the femoral stem and tibial stem at the cement to implant interface.Cement manufacturer is unknown.Update 8/24/2017 and 8/30/2017 der and records reviewed for reportability.It was identified and confirmed with depuy product engineer for lps system that the usage of the le intrcl str d tail assm 55mm with lps cemented stem 12x125mm str and lps cem fem stem 13x150mm bow as a construct across the patient's knee joint (stem cemented in distal femur and stem cemented in proximal tibia, with the le intrcl str d tail assm 55mm bridging the knee joint) to functionally fuse the knee joint (see included x-rays) is an off label use of these products and possibly the reason for their failure, requiring revision surgery.Complaint updated on: 9/21/2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other related incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS CEMENTED STEM 12X125MM STR
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6886713
• Report Number: 1818910-2017-25252
• Device Sequence Number: 10927584
• Product Code: JDI
• UDI-Device Identifier: 10603295079170
• UDI-Public: 10603295079170
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 198725412
• Device Lot Number: 155082
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/19/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 109