MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2.5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-22-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed due to infection.Poly exchange and washout completed.
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
Additional information received: 1.Both hip and knee components were listed in this complaint.Did the patient have both their knee and their hip revised? could you please provide some more information regarding the patient's history and revision? yes they had both knees and right hip the patient has a lot of metal work in their body.In addition to both hips, both knees were replaced she had also had a spinal cord stimulator and a spinal fusion.The surgeon suspected that this patient may have had a low grade infection that found its way into the knees and hip.2.Please advise the dates and details (surgeon, hospital, etc.) of the patient's primary surgery(s) (original implantation of depuy components for both hip and knee, if both were revised).Right total knee 2013 left total knee 2014 right total hip 2017 3.If the patient had depuy components revised in both their knee and their hip on the date listed in this complaint, please advise which sides were involved (left/right kip/knee).Right hip left knee right knee the current complaint (b)(4) captures the revision procedure for the patient's right knee.(b)(4) captures the revision procedure for the patient's left knee.(b)(4) captures the revision procedure for the patient's right hip.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation found wear on the condyles inner surface of the device, also some extraction damage can be seen.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.

• Brand Name: SIGMA STAB GVF INS 2.5 8MM
• 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): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16096141
• Report Number: 1818910-2023-00380
• Device Sequence Number: 17846649
• Product Code: JWH
• UDI-Device Identifier: 10603295064084
• UDI-Public: 10603295064084
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 01/04/2023

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 Model Number: 1581-22-010
• Device Catalogue Number: 158122008
• Device Lot Number: D12121380
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 02/17/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/20/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2012
• 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: DELTA CER HEAD 12/14 32MM +1; PFC* MOD + TIB TRAY SZ 2.5; PFC*SIGMA C/S NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; PINN MAR +4 10D 32IDX48OD; SIGMA STAB GVF INS 2.5 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female