MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL SLEEVE

Catalog Number UNK KNEE TIBIAL SLEEVE

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Joint Laxity (4526); Insufficient Information (4580)

Event Date 02/26/2022

Event Type  Injury  

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.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: hannon cp, stuart mb, abdel mp, pagnano mw, trousdale rt.Revision total knee arthroplasty with a rotating-hinge prosthesis mated to a well-fixed femoral sleeve.J arthroplasty.2022 jun;37(6s):s270-s275.Doi: 10.1016/j.Arth.2022.02.075.Epub 2022 feb 26.Pmid: 35227812.Objective and methods: the purpose of this study is to retrospectively review and compare survivorship, radiographs, and clinical outcomes of a rotating-hinge total knee arthroplasty mated to a new metaphyseal sleeve vs a well-fixed sleeve in 60 patients with tc3 knees who were revised to srom noiles knees between 1998 and 2019.The authors provide patient specific detail for the 9 patients who retained their well-fixed femoral sleeve during revision.The remaining 51 revisions which required femoral sleeve revision will be captured together.The authors indicate the tc3 knees were either primary or revision.There was insufficient information provided to identify the primary tka devices.The article notes that each tc3 had a femoral and tibial stem and sleeve, a femoral adaptor and bolt, and a patella.The manufacturer of the cement utilized in the tkas is unknown.The authors indicate a number of adaptors and bolts were fractures necessitating femoral component and/or femoral sleeve revision.The actual number of fractured bolts and adaptors is unknown but will be assumed to be associated with the instability and loosening.Additionally, the authors indicate there was periarticular metallosis associated with the fractured bolts and adaptors.Non-patient specific results: the authors do no provide sufficient information to associate these events with one of the identified patients.The following are the reasons for revision for the 51 patients who required a femoral sleeve revision: 22 revisions for infection 19 revisions for instability 2 revisions for aseptic loosening of an unspecified device 2 revisions to treat arthrofibrosis 2 for other unspecified reasons unknown number of intraoperative metallosis associated with bolt and adaptor fracture.Patient specific results: patient 1: femoral component, femoral bolt, femoral adaptor, and insert were revised to treat global instability.The authors indicate the femoral adaptor and bolt were fractured and there was metallosis secondary to the fracture.The patient was revised with an s-rom noiles tc3 hinged femoral component and lcs insert.Patient 2: all devices were revised to treat global instability including a femoral stem, sleeve, femoral component, adaptor and adaptor bolt, tibial inset, tray, tibial sleeve, tibial stem, and patella.The authors indicate that the femoral adaptor bolt and adaptor may have been fractures with associated metallosis.The patient received an srom noiles hinged revision construct which was re-revised to treat chronic infection by final follow-up.Patient 3: all devices were revised to treat extensor mechanism disruption including a femoral stem, sleeve, femoral component, adaptor and adaptor bolt, tibial inset, tray, tibial sleeve, tibial stem, and patella.The authors indicate that the femoral adaptor bolt and adaptor may have been fractures with associated metallosis.The patient received an srom noiles hinged revision construct which was re-revised to treat loosening of the tibial and femoral components by final follow-up.There is no indication that the tibial insert or patella were associated with the loosening of the femoral and tibial products and will therefore be included as concomitant products.Patient 4: femoral component, femoral bolt, femoral adaptor, and insert were revised to treat arthrofibrosis.The authors indicate the femoral adaptor and bolt may have been fractured was metallosis secondary to the fracture.The patient was revised with an s-rom noiles tc3 hinged femoral component and lps insert patient 5: femoral component, femoral bolt, femoral adaptor, and insert were revised to treat extensor mechanism disruption.The authors indicate the femoral adaptor and bolt may have been fractured was metallosis secondary to the fracture.There is no indication that the patella was revised, but it is included in the complaint as it is associated with the extensor mechanism.The patient was revised with an s-rom noiles tc3 hinged femoral component and lps insert patient 6: femoral component, femoral bolt, femoral adaptor, and insert were revised to treat arthrofibrosis.The authors indicate the femoral adaptor and bolt may have been fractured was metallosis secondary to the fracture.The patient was revised with an s-rom noiles tc3 hinged femoral component and lps insert.Patient 7: femoral component, femoral bolt, femoral adaptor, and insert were revised to treat arthrofibrosis.The authors indicate the femoral adaptor and bolt may have been fractured was metallosis secondary to the fracture.The patient was revised with an s-rom noiles tc3 hinged femoral component and lps insert.Patient 8: patient received a revision of the femoral component, adaptor bolt, and adaptor to treat loosening secondary to fracture of the bolt and adaptor.The authors indicate there was associated metallosis that was debrided during the revision.The insert was revised to accommodate the new srom noiles hinged femoral component.As the loosening and revision are associated with the fracture of the bolt and adaptor, the insert will be added as a concomitant product.Patient 9 patient received a revision of the femoral component, adaptor bolt, and adaptor to treat loosening secondary to fracture of the bolt and adaptor.The authors indicate there was associated metallosis that was debrided during the revision.The insert was revised to accommodate the new srom noiles hinged femoral component.As the loosening and revision are associated with the fracture of the bolt and adaptor, the insert will be added as a concomitant product.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN KNEE TIBIAL SLEEVE
• Type of Device: KNEE TIBIAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15040308
• MDR Text Key: 296051984
• Report Number: 1818910-2022-13169
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL SLEEVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention