MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR TIBIAL TRAY SZ4; KNEE TIBIAL TRAY

Catalog Number	129432140
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Synovitis (2094); Tissue Damage (2104); Joint Swelling (2356); Joint Disorder (2373)
Date of Event	08/11/2017
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
Change of lcs cementless tibia because patient is suffering from gout.Intraoperatively it had been necessary to also revise femur because as there was very constrictive space.Surgeon is wondering whether there was bone ingrowth at tibial and femoral component and asks us to investigate on this.Update (b)(6) 2017: translated medical records reviewed.Primary procedure notes (b)(6)2016 indicate the patient received a left total knee replacement due to laterally pronounced osteoarthritis of the entire left knee with chondromalacia.Procedure completed without indication of complication by the surgeon.Office notes (b)(6) 2017 indicate a bone scan was performed.Findings include persistent synovial hyperemia in the left knee joint, consistent with synovitis.No evidence of loosening of the total knee replacement.It is also indicated within this note that the patient received radiosynoviorthesis on (b)(6) 2016.It was recommended that he be treated with this again due to the continuing synovitis.Office notes (b)(6) 2017 indicate a bone scan was performed.Findings include persistent synovitis in the left knee joint.The increase in bone metabolism at the tibial prosthetic part must be assessed during progression as a loosening reaction, inflammatory.Patient complains of pain and swelling revision notes (b)(6) 2017 indicate the patient received a left total knee revision.Diagnosis includes synovitis in the left knee joint; capsular fibrosis in left knee joint.Aseptic loosening in the tibial region of the prosthetic left knee joint is also indicated in the diagnosis.However, the surgeon goes on to note the following intra-operatively: ¿reactive synovitis with a slightly vitreous appearance, with severe adhesions.The tibial plateau is not definitely loose.The femoral part of the prosthesis is also fixed in place.There are no traces of wear on the prosthesis or on the inlay.Complete synovectomy is performed, which is sent for histological analysis.As the tibial prosthesis and the inlay cannot be removed as they stand due to the poor flexion, the decision is taken to remove the endoprosthesis completely.¿ he also indicates that the contact surfaces of the tibial prosthesis required to be weekend before removal could occur.Therefore, it is reasonable to conclude that loosening of the tibial component did not occur.Updated (b)(6) 2017.
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.  product complaint # (b)(4).Investigation summary: 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: 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 will be filed as appropriate.
Event or Problem Description
Complaint description: change of lcs cementless tibia because patient is suffering from gout.Intraoperatively it had been necessary to also revise femur because as there was very constrictive space.Surgeon is wondering whether there was bone ingrowth at tibial and femoral component and asks us to investigate on this.Update sep 7, 2017: translated medical records reviewed.Primary procedure notes (b)(6) 2016 indicate the patient received a left total knee replacement due to laterally pronounced osteoarthritis of the entire left knee with chondromalacia.Procedure completed without indication of complication by the surgeon.Office notes (b)(6) 2017 indicate a bone scan was performed.Findings include persistent synovial hyperemia in the left knee joint, consistent with synovitis.No evidence of loosening of the total knee replacement.It is also indicated within this note that the patient received radiosynoviorthesis on (b)(6) 2016.It was recommended that he be treated with this again due to the continuing synovitis.Office notes (b)(6) 2017 indicate a bone scan was performed.Findings include persistent synovitis in the left knee joint.The increase in bone metabolism at the tibial prosthetic part must be assessed during progression as a loosening reaction, inflammatory.Patient complains of pain and swelling revision notes (b)(6) 2017 indicate the patient received a left total knee revision.Diagnosis includes synovitis in the left knee joint; capsular fibrosis in left knee joint.Aseptic loosening in the tibial region of the prosthetic left knee joint is also indicated in the diagnosis.However, the surgeon goes on to note the following intra-operatively: ¿reactive synovitis with a slightly vitreous appearance, with severe adhesions.The tibial plateau is not definitely loose.The femoral part of the prosthesis is also fixed in place.There are no traces of wear on the prosthesis or on the inlay.Complete synovectomy is performed, which is sent for histological analysis.As the tibial prosthesis and the inlay cannot be removed as they stand due to the poor flexion, the decision is taken to remove the endoprosthesis completely.¿ he also indicates that the contact surfaces of the tibial prosthesis required to be weekend before removal could occur.Therefore, it is reasonable to conclude that loosening of the tibial component did not occur.Updated 10-6-2017.

• Brand Name: MBT POR TIBIAL TRAY SZ4
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6925934
• Report Number: 1818910-2017-26176
• Device Sequence Number: 1409047
• Product Code: NJL
• UDI-Device Identifier: 10603295025702
• UDI-Public: 10603295025702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 129432140
• Device Lot Number: 8139341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 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: 54 YR