MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG FLUT FEMROD 5DG18X125MM; SIGMA REVISION IMPLANT : KNEE STEMS

Model Number	96-0703
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069); Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/06/2019
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.Patient: surgical intervention.
Event or Problem Description
It was reported that stem fragment was removed last (b)(6) 2019.Doi: (b)(6) 2012 (femoral stem).(b)(6) 2019 (femoral).Dor: (b)(6) 2019.
Additional Manufacturer Narrative
Product complaint # (b)(4).
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.
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.
Additional Manufacturer Narrative
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.Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIG FLUT FEMROD 5DG18X125MM
• Common Device Name: SIGMA REVISION IMPLANT : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9452552
• Report Number: 1818910-2019-122437
• Device Sequence Number: 3067363
• Product Code: JWH
• UDI-Device Identifier: 10603295233640
• UDI-Public: 10603295233640
• Combination Product (Y/N): N
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 96-0703
• Device Catalogue Number: 960703
• Device Lot Number: D12020941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019; 01/10/2020; 01/10/2020; 02/17/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/17/2019; 01/22/2020; 02/07/2020; 02/17/2020
• 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: P.F.C.* FLUT TIB ROD 75X18MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM STEM BOLT; PFC*SIGMA DIS AUG 8MM,SZ4,LEFT; PFC*SIGMA TC3 FEM LEFT SZ4; PFC*SIGMA TC3 INS17.5MM,SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention