MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP MODREV FEM CEM L STD+; LCS COMPLETE : KNEE FEMORAL

Catalog Number	129442050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Swelling (2091); Weakness (2145); Joint Disorder (2373); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Date of Event	05/05/2014
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
Fracture of a lcs revision component (femoral, posterior-condyle).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned devices confirms the reported event.Product problem has not been identified.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, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Updated 27 feb 2019: lcs claim letter received.Claim letter alleges cracked femoral component which in turn caused a distal femur fracture resulting to severe pain, instability, mobility restriction, walking difficulty, reduced leg length of the left lower extremity, muscle weakening, swelling and hematoma of the left knee joint.Doi: (b)(6) 2011; dor: (b)(6) 2014; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned devices confirms the reported event.Product problem has not been identified.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 device history lot : null.Device history batch : null.Device history review : null.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.

• Brand Name: LCS COMP MODREV FEM CEM L STD+
• Common Device Name: LCS COMPLETE : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7312718
• Report Number: 1818910-2018-54513
• Device Sequence Number: 1826973
• Product Code: NJL
• UDI-Device Identifier: 10603295026174
• UDI-Public: 10603295026174
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2018

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: 129442050
• Device Lot Number: 3148187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/15/2018; 10/25/2018; 02/27/2019
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/20/2018; 10/25/2018; 03/11/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 84