MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 2; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0012
Medical Device Problem Codes	Noise, Audible (3273); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for pain resulting from femoral component loosening.Event is serious and is considered severe.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2014; date of event: (b)(6) 2022; date of revision: unk; right knee.Treatment: revision of the femoral component and insert.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Implant noise cannot be confirmed only by xray images since this is a multifactorial event.Also, it cannot be determine a progressive decay of implant position in relation to initial implantation position.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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14955211
• Report Number: 1818910-2022-12563
• Device Sequence Number: 12127438
• Product Code: JWH
• UDI-Device Identifier: 10603295232018
• UDI-Public: 10603295232018
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 96-0012
• Device Catalogue Number: 960012
• Device Lot Number: 7915277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 1 40G; PFC SIGMA C/R NPOR FEM RT SZ 2; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 2; SIGMA PLI XLK INS 2 15MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female