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

Model Number	96-0771
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Revision on (b)(6) 2020 of previously revised knee to treat bone loss secondary to aseptic femoral implant loosening.An attune revision was used to revise a tc3.Original revision surgery (tc3) was conducted on (b)(6) 2009.Reason for re-revision was femoral loosening (femur + stem construct).The original mbt revision was still well fixed so didn't require removal/replacement.Tc3 femur + stem was removed.Insert was removed.Attune revision femur, sleeve and stem implanted.Attune revision crs insert implanted into original mbt tray (not indicated).
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: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed corrected: b1 (product problem), g1, h6 (clinical and medical device problem codes).B1 (product problem) should not have been checked, as there was no reported product problem.H6 clinical code: retracting the reported code for inadequate osseointegration.

• 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: 10757978
• Report Number: 1818910-2020-23596
• Device Sequence Number: 19104217
• Product Code: JWH
• UDI-Device Identifier: 10603295233909
• UDI-Public: 10603295233909
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Model Number: 96-0771
• Device Catalogue Number: 960771
• Device Lot Number: DW2VF4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/05/2021
• 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: MBT REVISION CEM TIB TRAY SZ 5; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT; PFC*SIGMA DIS AUG 4MM,SZ5,LEFT; PFC*SIGMA TC3 FEM LEFT SZ5; PFCSIG +/-2FEMOFFSET STMBLT; PFCSIG FLUT FEMROD 5DG18X125MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; TC3 RP TIBIAL INSERT S5,20.0
• Outcome Attributed to Adverse Event: Required Intervention