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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/17/2015
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical adverse event received for 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: 09/15/2015, date of event (onset): 09/03/2015, (left knee).Treatment: revised on (b)(6) 2015, all depuy products explanted.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.H10 additional narrative: added: b5, d4 (expiration date) and h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3, d6a, d6b.
Event or Problem Description
Additional information: bmi: 38.6.Event description of (b)(4), "rec'd 22oct15, left knee; 1) ae/infection-deep.Moderate severity.Serious, definitely not device related and definitely procedure related.Treatment: revision.2) revision/infection - deep.Femoral, tibial & insert revised.Diagnosis for primary knee surgery : osteoarthritis.Update rec'd 04 november 2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.The records indicate the patient was also revised to address ongoing pain.At this time there is no new information that would change the existing mdr decision".Complaint category - resulting patient harm.Ortho : infection.Ortho : pain.Original implant date: (b)(6) 2015.Event date: (b)(6) 2015.

• 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
• MDR Report Key: 11373619
• Report Number: 1818910-2021-03767
• Device Sequence Number: 934717
• Product Code: NJL
• UDI-Device Identifier: 10603295230410
• UDI-Public: 10603295230410
• 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 Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 05/13/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/11/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 2G 40G.; DEPUY DUOFIX MBT TRAY SZ 4.; PFC SIG RPF INS SZ 4 10MM.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIG PS150 FEM COMP SZ 4 L.; DEPUY CMW 2G 40G; DEPUY DUOFIX MBT TRAY SZ 4; PFC SIG RPF INS SZ 4 10MM; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG PS150 FEM COMP SZ 4 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 109