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
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Osteolysis (2377); Unspecified Tissue Injury (4559)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
Additional information received indicated that the patella was natural.
Additional 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1818910-2022-24377
• Device Sequence Number: 15128200
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/19/2022; 12/30/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/08/2022; 12/22/2022; 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2001
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA MOD TIB TRAY CEM SZ2; PFC*SIGMA C/R NPOR FEM LT SZ 2; PFCSIG POSTLIP INSERT SZ2 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown