MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number	1294-53-235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical adverse event received for patellar clunk and irritation.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2014, date of event: (b)(6) 2020, (right knee).Treatment: arthroscopy.
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
Original tka was an intermedics done in (b)(6) city.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: (b)(6) 2020, confirmation was made that the arthroscopy has not taken place at this time.There has been no revision, no invasive treatment, no serious injury to report.The previous decision has been downgraded from serious injury to not reportable due to the additional information received.Correction: this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.Manufacturing report number 1818910-2020-21755, is retracted due to the additional information received.

• Brand Name: UNIVERSAL FEM SLV DIS POR 40MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10646437
• Report Number: 1818910-2020-21755
• Device Sequence Number: 11417518
• Product Code: JWH
• UDI-Device Identifier: 10603295026327
• UDI-Public: 10603295026327
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-53-235
• Device Catalogue Number: 129453235
• Device Lot Number: 586133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/09/2020; 11/18/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/16/2020; 11/19/2020
• 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: DEPUY CMW 2 20G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,22.5; UNIVERSAL FEM SLV DIS POR 40MM; DEPUY CMW 2 20G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,22.5; UNIVERSAL FEM SLV DIS POR 40MM
• Patient Age: 73 YR
• Patient Weight: 100