MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC*SIGMA/OV/DOME PAT 3PEG,35; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number 960101

Device Problem Off-Label Use (1494)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

We implanted an attune knee prosthesis with a sigma patella button.As soon as we identified the discrepancy, the theatre team made contact with you to confirm if the patella button used was compatible with the knee prosthesis implanted, to which you confirmed.Patient was take back to theatre the following day to replace a component of their knee replacement system.

Event Description

Additional information was received: it wasn't an attune patella implanted it was a sigma patella with attune femur/ insert and tibia hence the reporting and complaint.Product code: 960101, lot: d23023165.Surgery date on (b)(6) 2024.Revision surgery on (b)(6) 2024.No adverse effects but prolonged hospital stay by one day and another surgery.

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 code.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : we implanted an attune knee prosthesis with a sigma patella button.As soon as we identified the discrepancy, the theatre team made contact with you to confirm if the patella button used was compatible with the knee prosthesis implanted, to which you confirmed, it was not (as per the email below).Today, we have submitted the prosthesis data into the njr database and this has not identified a discrepancy in the items originally implanted, which i find a little perplexing.Please can i confirm that depuy have informed the njr that these items are not compatible as this is not highlighted as a mismatch which is a significant concern for the efficacy of the njr system? as it currently stands, from an njr perspective, we have taken a patient back to theatre the following day to replace a component of their knee replacement system which was reported as compatible.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation was reviewed, however it is not representative of the reported complaint.However with he information provided, it is possible to confirm the complaint.Please refer to stg sigma primary knee system, page 55, under warning and precautions caution note; "implants and trial components from different manufacturers or implant systems should never be used together." as the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the investigation performed on pfc*sigma/ov/dome pat 3peg,35 would contribute to the reported allegation.Based on the investigation findings, potential cause can be traced to user and 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 : 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.

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18856000
• MDR Text Key: 337103965
• Report Number: 1818910-2024-05309
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232612
• UDI-Public: 10603295232612
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P830055
• 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: 03/07/2024

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 Catalogue Number: 960101
• Device Lot Number: D23023165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/11/2024; 05/06/2024
• Supplement Dates FDA Received: 03/13/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ATTUNE CR FB INSRT SZ 6 6MM.; ATTUNE CR FEM RT SZ 6 CEM.; ATTUNE FB TIB BASE SZ 8 CEM.
• Patient Outcome(s): Required Intervention