MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMPLETE FEM POR R LG; KNEE FEMORAL COMPONENT

Catalog Number	129403060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Tissue Damage (2104); Joint Swelling (2356); Osteolysis (2377)
Date of Event	06/22/2015
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
The patient was revised to address pain.Update 9-22-2017 and 9-27-2012.Medical records reviewed.Pre- revision notes indicate upon clinical examination, the patients knee is swollen.There is a large effusion present.X-rays taken revealed a large area of lysis in the anterior part of the peg in the tibia and no evidence of any fracture, however it did look expansive.Brief revision operative note (b)(6) 2015 reveals the patient received a first stage excision arthroplasty right knee.Findings include gross tibial lysis, tibial medial defect beneath mcl, patellar tendon with tubercle still attached.No anteromedial bone.Cortical sheel of loose fractured anterolateral tibia.The surgeon determined the joint was not reconstructable with tc3 & augments due to concerns about underlying infection.Proximal tibial 1st stage carried out with spacer & debridement.Medical records indicate the patient was re-implanted in (b)(6) 2015, it is unknown what products were implanted at this time.It is then indicated that a right transtibial amputation was performed on (b)(6) 2015 due to persistently infected right proximal tibial replacement with graft /flap breakdown.Insufficient information is available to determine if depuy products were involved.If this information becomes available this will be re-addressed.Please also note that concerns of infection are addressed during the 1st stage explanation, however, there has been no verification of infection at that time.If this information is received it will be re-addressed.
Additional Manufacturer Narrative
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.
Event or Problem Description
Complaint description: the patient was revised to address pain.Update 9-22-2017 and 9-27-2012.Medical records reviewed.Pre- revision notes indicate upon clinical examination, the patients knee is swollen.There is a large effusion present.X-rays taken revealed a large area of lysis in the anterior part of the peg in the tibia and no evidence of any fracture, however it did look expansive.Brief revision operative note jun 22, 2015 reveals the patient received a first stage excision arthroplasty right knee.Findings include gross tibial lysis, tibial medial defect beneath mcl, patellar tendon with tubercle still attached.No anteromedial bone.Cortical sheel of loose fractured anterolateral tibia.The surgeon determined the joint was not reconstructable with tc3 & augments due to concerns about underlying infection.Proximal tibial 1st stage carried out with spacer & debridement.Medical records indicate the patient was re-implanted in sep 2015, it is unknown what products were implanted at this time.It is then indicated that a right transtibial amputation was performed on (b)(6) 2015 due to persistently infected right proximal tibial replacement with graft /flap breakdown.Insufficient information is available to determine if depuy products were involved.If this information becomes available this will be re-addressed.Please also note that concerns of infection are addressed during the 1st stage explanation, however, there has been no verification of infection at that time.If this information is received it will be re-addressed.Updated 10-19-2017.
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.Product complaint # (b)(4).The reported event has been evaluated and will be monitored.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 : 1100830.Device history batch : null.Device history review : no anomalies noted 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 FEM POR R LG
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6965255
• Report Number: 1818910-2017-27092
• Device Sequence Number: 19157780
• Product Code: NJL
• UDI-Device Identifier: 10603295021711
• UDI-Public: 10603295021711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2017

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: 129403060
• Device Lot Number: 1100830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 07/11/2018
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/23/2017; 07/24/2018
• 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: 73 YR