MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ2; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number 86-6022

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Osteolysis (2377); Unspecified Tissue Injury (4559)

Event Date 11/15/2022

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

They were implanted in (b)(6) 2001.Revised due to failure of the metaphyseal bone of the tibia.The surgeon does not require any feedback.Doi: (b)(6) 2001.Dor: (b)(6) 2022.Right knee.

Event Description

Additional information received indicated that the patella was natural.

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.H10 additional narrative:  added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h4.

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, post market surveillance, 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 : 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).A manufacturing records evaluation (mre) was not performed.

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.Corrected h6: (clinical and device codes).

Event Description

Additional information received.A.What was the affected side? left, or right? right side.B.Was there any surgical delay? if yes, please provide the details.None.C.How did the failure of the metaphyseal bone present itself? the tibial tray had subsided on the medial side.D.Was the tibial tray loose? and if so, at what interface? yes, cement bone.E.Was there osteolysis of the tibial metaphyseal bone? or was there a fracture of the tibial bone? some osteolysis.F.Was there any reported tibial collapse (medial or lateral) or tibial tray implant subsidence? yes, medial.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ2
• Type of Device: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15923838
• MDR Text Key: 304884693
• Report Number: 1818910-2022-24377
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-6022
• Device Catalogue Number: 866022
• Device Lot Number: 951892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2001
• 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 MOD TIB TRAY CEM SZ2; PFC*SIGMA C/R NPOR FEM LT SZ 2; PFCSIG POSTLIP INSERT SZ2 10MM
• Patient Outcome(s): Required Intervention