MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL

Catalog Number UNK KNEE FEMORAL

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

(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

Literature article entitled, " midterm assessment of causes and results of revision total knee arthroplasty".Literature article "midterm assessment of causes and results of revision total knee arthroplasty" (2010) by fahad hossain mrcs, shelain patel mrcs, fares sami haddad frcs (tr & orth) published by clinical orthopaedics and related research doi 10.1007/s11999-009-1204-0 was reviewed for mdv reportability.The article purpose: to compare patient outcomes, survivorship and modes of failure and the most common etiologic factors for rerevision between different revision implant types.The authors retrospectively reviewed 349 cases of revision tka in 343 patients whose mean age was 67.8 years.Three implant types were used: posterior stabilized, condylar constrained knee, and rotating hinge.The first two types were depuy products, but the rh implant type consisted of both depuy and competitor products.Most cck and all rh implant were stemmed.Cemented stem fixation would be reserved for the elderly population or those with osteoporotic bone except in cases of the rh implant in which we favor cemented stem fixation.Cement manufacturer was not disclosed in the article.Two hundred four patients underwent patellar resurfacing.Of the remainder, 79 had their previously resurfaced patella retained and 66 were deemed unreconstructable.All cases in the cck and rh groups had revision of all components of the index procedure with 16 cases in the ps group undergoing a single component revision on either the tibial or femoral side.The article reports: the most common reason for revision tka amongst all patients was infection (114 patients).Aseptic loosening (52 patients), polyethylene wear (43 patients), and conversion of uka resulting from disease progression (29 patients) were other common modes of failure requiring revision tka.One hundred seven (85%) patients in the ps group, 122 (82%) patients in the cck group, and 65 (88%) patients in the rh group were satisfied with their revision tka.Cement usage was determined through surgeon discretion and the cement manufacturer was not disclosed.The aseptic loosening, infection, stiffness, fracture.Joint instability, or tendon injuries noted in the literature article are assigned to any product does the article detail how many patients experienced these harms.As such, we'll proceed by assuming they were found in all three product lines.Additionally, the loosening events mentioned are not elaborated upon; therefore, the specific component that's loosening is unknown with the information presented thus both the femoral and tibial components are assigned the loosening code.Furthermore, the fractures are also not elaborated upon and therefore we can't be certain whether these were bone or implant fractures nor can we ascertain where the fractures occurred.Finally, the rerevisions presented in the literature article due to "patella" are not expanded upon therefore the precise patellar failures are not fully understood.The first three ip's are for the pfc sigma implants, the next three ip's are for the s-rom noiles implants, and the final 4 ip's are for the tciii implants (this was the only system which the patella was noted as causing a patient harm).

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.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.------------------------------------------------------------ the complaint was received into the company in the form of a literature paper with the following comment: literature article "midterm assessment of causes and results of revision total knee arthroplasty" (2010) by fahad hossain mrcs, shelain patel mrcs, fares sami haddad frcs (tr & orth) published by clinical orthopaedics and related research doi 10.1007/s11999-009-1204-0 no products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: the article purpose: to compare patient outcomes, survivorship and modes of failure and the most common etiologic factors for rerevision between different revision implant types.The authors retrospectively reviewed 349 cases of revision tka in 343 patients whose mean age was 67.8 years.Three implant types were used: posterior stabilized, condylar constrained knee, and rotating hinge.The first two types were depuy products, but the rh implant type consisted of both depuy and competitor products.Most cck and all rh implant were stemmed.Cemented stem fixation would be reserved for the elderly population or those with osteoporotic bone except in cases of the rh implant in which we favor cemented stem fixation.Cement manufacturer was not disclosed in the article.Two hundred four patients underwent patellar resurfacing.Of the remainder, 79 had their previously resurfaced patella retained and 66 were deemed unreconstructable.All cases in the cck and rh groups had revision of all components of the index procedure with 16 cases in the ps group undergoing a single component revision on either the tibial or femoral side.The article reports: the most common reason for revision tka amongst all patients was infection (114 patients).Aseptic loosening (52 patients), polyethylene wear (43 patients), and conversion of uka resulting from disease progression (29 patients) were other common modes of failure requiring revision tka.One hundred seven (85%) patients in the ps group, 122 (82%) patients in the cck group, and 65 (88%) patients in the rh group were satisfied with their revision tka.Cement usage was determined through surgeon discretion and the cement manufacturer was not disclosed.The aseptic loosening, infection, stiffness, fracture.Joint instability, or tendon injuries noted in the literature article are assigned to any product does the article detail how many patients experienced these harms.As such, we'll proceed by assuming they were found in all three product lines.Additionally, the loosening events mentioned are not ellaborated upon; therefore, the specific component that's loosening is unknown with the information presented thus both the femoral and tibial components are assigned the loosening code.Furthermore, the fractures are also not ellaborated upon and therefore we can't be certain whether these were bone or implant fractures nor can we ascertain where the fractures occurred.Finally, the rerevisions presented in the literature article due to "patella" are not expanded upon therefore the precise patellar failures are not fully understood.The first three ip's are for the pfc sigma implants, the next three ip's are for the s-rom noiles implants, and the final 4 ip's are for the tciii implants (this was the only system which the patella was noted as causing a patient harm).Without returned parts, no further investigation of the associated products can be made.No investigation as to manufacturing defects can be made without product codes and batch numbers.Post-market surveillance is per sep-419.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: UNKNOWN KNEE FEMORAL
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9131059
• MDR Text Key: 165587222
• Report Number: 1818910-2019-106660
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention