MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 10.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Both of these happened within the same case.1.Removal of sigma rp stab poly for a dair infection washout out + poly swap case.2.Primary arthroplasty surgeon had used a depuy synthes tibial implant (sigma pfc rp stab size 5 10mm) with a different comapany's cruciate retaining (cr) femoral component.Patient came into theatre for a dair infection washout + poly swap and [surgeon] swapped the stab poly out for a cr version of the poly.It is off label to use our tibial implants with another company's femoral implants, but surgeon did not want to do a full revision surgery whilst the patient was infected.Surgeon understood that it was contraindicated however said it was the best thing for the patient on the day.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: both of these happened within the same case 1.Removal of sigma rp stab poly for a dair infection washout out + poly swap case.2.Primary arthroplasty surgeon had used a depuy synthes tibial implant (sigma pfc rp stab size 5 10mm) with a different comapany's cruciate retaining (cr) femoral component (it looks like a howmedica implant, but records are not showing).Patient came into theatre for a dair infection washout + poly swap and [surgeon] swapped the stab poly out for a cr version of the poly.I had a conversation with him about the fact that it is off label to use our tibial implants with another comapany's femoral implants, but he said he did not want to do a full revision surgery whilst the patient was infected.Surgeon understood that it was contraindicated however said it was the best thing for the patient on the day and he will come back for a total revision surgery where all implants will be swapped.The product was not returned to depuy synthes; however photos were provided for review.See attachment poly 1.Jpg, poly 2.Jpg, poly 3.Jpg, poly 4.Jpg.The photo investigation revealed the pfc sigmarp stb tb in 5 10.0 was observed wear on the right condyle along with some pitting on the same side of the post.The condition is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.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 not confirmed as the observed condition of the pfc sigmarp stb tb in 5 10.0 would not contribute to the reported adverse event.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 reported 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: product code 962151 work order (b)(4) stb tb in 5 10.0 was manufactured on 28-oct-2016.(b)(4) parts were manufactured per specification and all raw materials met specification.There was one non-conformance reference on oms.(b)(4) is associated with this lot.However, this does not correlate to the complaint failure mode.Added: a1.Corrected: d4 primary udi number.

• Brand Name: PFC SIGMARP STB TB IN 5 10.0
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19126776
• Report Number: 1818910-2024-08499
• Device Sequence Number: 18225382
• Product Code: NJL
• UDI-Device Identifier: 10603295241386
• UDI-Public: (01)10603295241386(17)210930(10)8386333
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 962151
• Device Lot Number: 8386333
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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 SIGMARP CV TB/IN S5 10.0.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown