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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TIB TRAY CEM SZ3; KNEE TIBIAL TRAY

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DEPUY ORTHOPAEDICS INC US PFC SIGMA TIB TRAY CEM SZ3; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 866023
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Event Date 01/25/2024
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
 
Event Description
Hcp sent a medical info request to team: "i have a patient in the clinic who has developed symptoms since several weeks after implantation of a pfc modular plus prosthesis.Surgical date (b)(6) 2008: pfc modular right knee: femur cemented, size 4, tibia cemented, size 3, plateau height 10 mm stabilized; patellum shaping.The patient now presents and the images show the inlay as worn/defective with a defect on the dorsal medial tibial console and ventral subluxation of the tibia to the femur.It is clear that there will be a certain amount of metallosis with a dorsally rubbed tibial component.As the manufacturer, is it still permissible to change the inlay alone in the case of a dorsally impaired tibial component?".
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information was received: no allegation against patella.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "hcp sent a medical info request to team: "i have a patient in the clinic who has developed symptoms since several weeks after implantation of a pfc modular plus prosthesis.Surgical date (b)(6) 2008: pfc modular right knee: femur cemented, size 4, tibia cemented, size 3, plateau height 10 mm stabilized; patellum shaping.The patient now presents and the images show the inlay as worn/defective with a defect on the dorsal medial tibial console and ventral subluxation of the tibia to the femur.It is clear that there will be a certain amount of metallosis with a dorsally rubbed tibial component.As the manufacturer, is it still permissible to change the inlay alone in the case of a dorsally impaired tibial component?"".The product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) x-rays).The x-ray investigation revealed that pfc sigma tib tray cem sz3 appears to have nothing indicative of a device nonconformance.However, a shadow can be observed on pfc sigma tib tray cem sz3 lateral portion, suggesting a dissociation of the pfc sigma stab ins sz3 10mm.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the pfc sigma tib tray cem sz3 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 30-jan-2008.3) any anomalies or deviations identified in dhr: no.4) expiry date: 30-jan-2018.5) ifu reference: ifu-0902-00-252.
 
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Brand Name
PFC SIGMA TIB TRAY CEM SZ3
Type of Device
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18825863
MDR Text Key336774319
Report Number1818910-2024-04914
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295216780
UDI-Public10603295216780
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K884796
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/04/2024
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
Device Operator Health Professional
Device Expiration Date01/30/2018
Device Catalogue Number866023
Device Lot Number2549071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/04/2024
Supplement Dates Manufacturer Received03/13/2024
05/17/2024
Supplement Dates FDA Received03/19/2024
05/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PFC SIGMA STAB INS SZ3 10MM; PFC*SIGMA C/S NPOR FEM RT SZ 4; PFC*SIGMA/OV DOME PAT 3 PEG,32; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL INSERT
Patient Outcome(s) Required Intervention;
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