MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC* FLUT TIB ROD TRL 75 X 14; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Catalog Number 866876

Device Problems Material Fragmentation (1261); Off-Label Use (1494)

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/06/2019

Event Type  Injury  

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 Description

During a follow up xray at the office, it was realized that a 14x75mm trial stem was left in the patient¿s rt tibia after it disengaged from the tibial broach and was not noticed at the time of surgery.The trial was a 14/75mm universal stem trial.The surgeon revised the knee and the stem trial was successfully removed from the patient's tibia.

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).The device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.  udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).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.

Manufacturer Narrative

Product complaint # : (b)(4).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. .

Manufacturer Narrative

Product complaint # (b)(4).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: added: b5, b7, d11, h6 (no code available (3191) is used to capture the medical device removal).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Medical records received were reviewed by a clinician to identify patient harms/product issues.Primary operative notes (b)(6) 2016 indicate the patient received a right uni knee replacement due to medial compartment osteoarthritis and history of acl injury.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2018 indicate the patient is experiencing increasing pain and difficulty with ambulating.Radiographs reveal a somewhat flexed positioning of the femoral component and anterior translation of the tibial component, lateral compartment osteoarthritis is also present.Revision operative notes (b)(6) 2018 indicate the patient received a conversion to right total knee arthroplasty due to pain and posterior cruciate ligament rupture.Upon entering the knee, it was noted that both components were not worn, in good position and not loose.The knee itself was noted to be unstable posteriorly.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2019 indicate the patient is experiencing pain.Radiographs reveal a well-placed arthroplasty with tibial trial present within the joint.Allery testing reveals the patient has a metal allergy, specifically to nickel and vanadium.Revision operative notes (b)(6) 2019 indicate the patient received a right total knee revision due to retained right tibial hardware.Upon entering the joint, scar tissue was encountered and removed.The patella and femoral components were noted to be intact and in good position, they were not revised.The tibial component and retained trial were removed without complication.No indication of deficiency related to the tibial insert or tibial tray.The surgery was completed without indication of complication by the surgeon.Office notes (b)(6) 2019 indicate the patient has experienced lower leg nerve pain since the (b)(6) 2019 surgery.She is experiencing pain, tingling, numbness, swelling, feelings of instability and deceased range of motion relating to her right lower leg.Treatment includes pain medication and physical therapy.No indication of additional surgical intervention.

Manufacturer Narrative

Product complaint # = (b)(4).Investigation summary =update 04-feb-2021: the investigation was re-opened upon receipt of additional information.The device associated with this report was not returned for evaluation.Visual examination of the provided x-ray images confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Type of Device: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8351158
• MDR Text Key: 136522202
• Report Number: 1818910-2019-85095
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 866876
• Device Lot Number: 866875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 37MM; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG RP AOX STB INS SZ3 12.5; SIGMA PS CEM FEM SZ3 R; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR