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

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.

• 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 Key: 18825863
• MDR Text Key: 336774319
• Report Number: 1818910-2024-04914
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295216780
• UDI-Public: 10603295216780
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K884796
• Number of Events Reported: 1
• 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 Date: 01/30/2018
• Device Catalogue Number: 866023
• Device Lot Number: 2549071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 05/17/2024
• Supplement Dates FDA Received: 03/19/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• 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