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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2022
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 surgery for patella resurfacing for progression of patellofemoral pain with a pfc sigma fixed bearing total knee.Patella not resurfaced at original primary surgery.Native patella resurfaced at this revision.Doi: (b)(6) 2006; dor: (b)(6) 2022 unknown 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
Additional information was received indicating that the affected side involved in this event was the right knee.
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.
Event or Problem Description
Additional information received.1.Please clarify the affected side involved 2.Was the cement product manufactured by depuy? if yes, please provide the part and lot numbers and quantity of the cement.3.Was there any suggestion by anyone indicating that there was or maybe deficiency with the product(s).If yes, please provide details.4.During the surgery for the resurfacing of the natural patella, what was the reason for revising the tibial tray, insert, and femoral stem? 5.Patient demographics & comorbidities 2,3,4,5 i think it is the surgeon's case the cement is irrelevant as nothing cemented was revised from memory, i think it was a right knee.This is weeks ago but i don¿t think the tibia insert and femoral stem were revised.My apologies i am not of much help it is some weeks ago and i submit a couple of these a week.I provide all the information i have available and can provide without patient consent.I am a bit confused regarding the revision of anything other than a patella resurfacing.

• 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
• 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: 14186137
• Report Number: 1818910-2022-07275
• Device Sequence Number: 12002328
• Product Code: JWH
• UDI-Device Identifier: 10603295216438
• UDI-Public: 10603295216438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K830927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 86-4181
• Device Catalogue Number: 864181
• Device Lot Number: 2126033
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 05/11/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/09/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2006
• 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: CEMENT MFG AND PRODUCT NAME UNKNOWN; PFC KEEL TIB TRAY CEM SZ3; PFC*SIGMA C/R POR FEM LF SZ4; PFCSIG POSTLIP INSERT SZ3 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown