MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PFC SIG RPF INS SZ 5 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Model Number	95-1050
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2015
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
Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for polyethylene rotated/ spin out.Event is not 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: left knee revision on (b)(6) 2015 - tibial insert revised.
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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: dhr review was conducted on the pfc sig rpf ins sz 5 10mm (product code 951050, lot number 622303).Dhr review (b)(4), (product code 951050, lot number 622303).Dhr reviewed - no deviations or nonconformances were noted.
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, b6 and d4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.
Event or Problem Description
Clinical complaint (b)(4).Left knee revised on (b)(6) 2015, due to spin-out.Original surgery due to osteoarthritis.

• Brand Name: PFC SIG RPF INS SZ 5 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: 10836429
• Report Number: 1818910-2020-24556
• Device Sequence Number: 4246650
• Product Code: NJL
• UDI-Device Identifier: 10603295230458
• UDI-Public: 10603295230458
• 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,Followup
• Report Date (Section B): 10/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 95-1050
• Device Catalogue Number: 951050
• Device Lot Number: 622303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/17/2020; 01/18/2021; 01/25/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/26/2020; 01/22/2021; 01/25/2021
• 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 6.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIG PS150 FEM COMP SZ 5 L.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 117