MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG +/-2FEMOFFSET STMBLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960771
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/20/2019
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.
Event or Problem Description
Reporting a revision of sigma tc3 fixed bearing knee implants at royal lancaster infirmary.All components were removed without difficulty.It should be noted that upon removal of the femoral component, it was observed that the femoral component and the femoral adaptor were slightly loose and can be rotated ¿ questioning whether insufficient torque was used upon initial implant preparation by surgical team.The disassociation occurred between the bolt and the stem as this is a stem-bolt configuration.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present root cause undetermined.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.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).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.

• Brand Name: PFCSIG +/-2FEMOFFSET STMBLT
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9180948
• Report Number: 1818910-2019-109411
• Device Sequence Number: 11733638
• Product Code: JWH
• UDI-Device Identifier: 10603295233909
• UDI-Public: 10603295233909
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2019

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 Catalogue Number: 960771
• Device Lot Number: 266787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 12/12/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/21/2019; 12/16/2019
• 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 75X16MM; PFC SIGMA MOD TIB TRAY CEM SZ4; PFC*SIGMA DI AUG12MMCO,SZ5RGHT; PFC*SIGMA DIS AUG 8MM,SZ5,RGHT; SIGMA PS CEM FEM SZ5 R; SIGMA STAB GVF INS 4 15MM
• Outcome Attributed to Adverse Event: Required Intervention