MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT REV SLV LPS FEM ADP +0; KNEE FEMORAL ADAPTOR

Model Number	1511-06-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presents with a draining wound.Surgeon suspects infection and finds puss in the knee.Surgeon performs a one stage knee revision with a dual set up and placement of antibiotic beads.Two surgery dates relate to this der as a poly exchange was performed on (b)(6) 2021 where a der was submitted.Cement utilized was a depuy product, however part and lot info are unavailable as it is hospital owned and not on a paperwork.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed.It is not possible to confirm a depuy's product failure as well as a relation between the adverse event and the reported product.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.

• Brand Name: ATT REV SLV LPS FEM ADP +0
• Common Device Name: KNEE FEMORAL ADAPTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12922938
• Report Number: 1818910-2021-27000
• Device Sequence Number: 14893210
• Product Code: JWH
• UDI-Device Identifier: 10603295503408
• UDI-Public: 10603295503408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 11/18/2021

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: 1511-06-000
• Device Catalogue Number: 151106000
• Device Lot Number: JF7129
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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: ATT REV SLV LPS FEM ADP +0.; ATTUNE REV LPS INSRT XXSM 12MM.; ATUN FEM SLV M/L 30MM FULL POR.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE PRESSFIT STR STEM18X60MM.; ATUNE REV RP TIB BASE SZ 5 CEM.; CONTROL CABLE W/CABLE SLEEVE.; LPS DISTAL FEM COMP XXSM LT.; LPS SEGMENTAL COMPONENT 40MM.; LPS SEGMENTAL COMPONENT 65MM.; UNKNOWN BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 185 KG