MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG PS CEM FEM W/LUGS RT SZ4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-74-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/04/2021
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
It was reported that the patients right knee was revised due to instability.The initial procedure was a right tka done (b)(6) 2018.It was revised with a thicker poly on (b)(6) 2020.All components are being removed today, minus the patella.There was no surgical delay.Doi: (b)(6) 2018 (all implants except the insert), (b)(6) 2020 (tibial insert).Dir: (b)(6) 2021.Right knee.
Event or Problem Description
Questions: 1.Was the cement product manufactured by depuy? if yes, please provide the part and lot numbers and quantity of the cement.2.Please clarify, was the patellar implant removed? 3.It was indicated in the event description that patient was revised with a thicker poly on 3/10/20.Was this being reported? if yes, please provide the complaint number.3.1.If none reported, please provide details of the previous revision.4.Was instability related to polyethylene wear? 5.Was there any reported malposition of components that led to the instability? 6.Were any components undersized on the primary surgery that led to the instability? 7.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability.Answers: 1.Unknown what cement.2.Patella was retained.3.Original case # was 168118 ( i am attaching the mdr as there is no complaint # on it.5-7.No other than that, i have no further information.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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.

• Brand Name: SIG PS CEM FEM W/LUGS RT SZ4
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12638397
• Report Number: 1818910-2021-22784
• Device Sequence Number: 14315745
• Product Code: JWH
• UDI-Device Identifier: 10603295075486
• UDI-Public: 10603295075486
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1960-74-500
• Device Catalogue Number: 196074500
• Device Lot Number: HP7764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 11/15/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• 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: MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG PS CEM FEM W/LUGS RT SZ4; SIG RP AOX STB INS SZ4 15; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG PS CEM FEM W/LUGS RT SZ4; SIG RP AOX STB INS SZ4 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 117 KG