MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC KEEL TIB TRAY CEM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-4181
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/25/2021
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
Compass case (b)(4) reports: the patient was revised to address loosening of the tibial component at the bone to implant interface.The delay in the case was to cable the femur after implanting attune rev femur with a 30 sleeve and 14x60 stem.A surgical delay of 20 minutes.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Event or Problem Description
With regards to this, please confirm if any of the following information is available: 1.Was there any adverse consequences to patient due to the delay/event? 2.It was stated that the cable was performed after implanting of the attune revision femur with 30 sleeve and 14x260 stem.Was the a bone fracture? answer to your questions: 1.No further information available.2.Yes there was a bone fx.

• Brand Name: PFC KEEL TIB TRAY CEM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12453214
• Report Number: 1818910-2021-19828
• Device Sequence Number: 3726122
• Product Code: JWH
• UDI-Device Identifier: 10603295216438
• UDI-Public: 10603295216438
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K830927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 86-4181
• Device Catalogue Number: 864181
• Device Lot Number: 263524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; PFC KEEL TIB TRAY CEM SZ3; PFC SIGMA CRVD INSERT SZ3 8MM; PFC*SIGMA C/R NPOR FEM LT SZ 3; UNK MANUFACTURER & PRODUCT INFO; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM14X60MM; PFC KEEL TIB TRAY CEM SZ3; PFC SIGMA CRVD INSERT SZ3 8MM; PFC*SIGMA C/R NPOR FEM LT SZ 3; UNK MANUFACTURER & PRODUCT INFO
• Outcome Attributed to Adverse Event: Required Intervention