MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 4 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1040
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
Date of Event	09/03/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for infected left total knee replacement infection - deep.Event is serious and is considered moderate.Event is definitely not related to device and is definitely related to procedure.Date of implantation: (b)(6) 2015; date of event (onset): (b)(6) 2015; (left knee).Treatment: on (b)(6) 2015, revision of femur, tibial tray, and insert; patella component was retained.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.
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.
Event or Problem Description
1.On (b)(6) 2015, the patient had a left computer navigated total knee replacement to address gonarthrosis.Depuy components were used during this procedure, including depuy patella and depuy cement x1 (sticker sheet page 2 of 48).2.A letter dated (b)(6) 2015, noted the patient had pain and radiograph is noted show tibial component is loosening.* a.There was no side provided on the medical letter provided, the information correlates with an (b)(6) 2015 lab collection for left knee loosening.3.An operation record from (b)(6),2015, findings noted an infected left tkr.¿polyethylene and femoral component loosely cemented¿.There was a deep infection in the left (not right) knee, and a first stage of a 2-stage revision.Prior medical records note the patient was experiencing pain prior to the revision.A.No mention of tibial component loosening in the short operation records b.On (b)(6) 2015 (sticker page 12/48 femoral component, cement x2, and insert ) left knee c.** dates in #3, provided range from (b)(6) 2015, but it would be reasonable to conclude that they pertain to the same event.4.A letter dated (b)(6) 2016, the patient is noted to have some pain with effusion.No side provided on the letter, but it would be reasonable to assume the left knee.5.On (b)(6) 2016 patient had a washout and revision of left knee (b)(6), 2016 as the patient¿s knee was still infected.The temporary implants were removed and antibiotic impregnated spacers were placed.An ultrasound guided left knee aspiration was collected on (b)(6), 2016, revealed joint effusion with synovial thickening.6.(b)(6) 2016, radiographs are noted to show lucencies surrounding the surgical material unchanged from (b)(6), 2016, there is a small knee effusion 7.(b)(6), 2016, the medical records, patient was noted to have second stage revision left total knee replacement for infection on (b)(6), 2016.8.Sticker page 41/48 with depuy components.No date on sticker sheet.It is revision knee products for the left knee, presumably implanted on (b)(6),2016.
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, and h6 (patient,device) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PFC SIG RPF INS SZ 4 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 13282986
• Report Number: 1818910-2022-01065
• Device Sequence Number: 11970602
• Product Code: NJL
• UDI-Device Identifier: 10603295230410
• UDI-Public: 10603295230410
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/17/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 95-1040
• Device Catalogue Number: 951040
• Device Lot Number: 621488
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/01/2022; 04/14/2022; 04/14/2022; 04/30/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/02/2022; 04/18/2022; 04/29/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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: DEPUY CMW 2G 40G; DEPUY DUOFIX MBT TRAY SZ 4; SIG PS150 FEM COMP SZ 4 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 109 KG