MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; KNEE TIBIAL TRAY

Model Number	1506-80-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed secondary to infection.Patient originally implanted with a non depuy synthes uni-compartmental knee and revised to this current prosthesis.Dair procedure.
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
1.Please clarify, what were the products removed due to infection? based on the impacted products reported, only the product return status of the tibial insert was discarded.2.Can you confirm the primary surgery date or the original implantation date? 3.Was there any suggestion by anyone indicating that there was or may be deficiency with the product(s).If yes, please provide details.4.Was the cement product manufactured by depuy? if yes, please provide the part and lot numbers and quantity of the cement.5.Can you please provide the lot number for the reported products (attune ps fem rt sz 9 cem) and (attune medial dome pat 41mm)? 6.Patient demographics & comorbidities 7.Radiographs/x-ray films and op notes if available.Response: i have provided all the information available.The only implant revised was the bearing as it is a washout or dair procedure for infection as reported.Dair is debridement, antibiotics, implant retention, a procedure for infection while retaining the prothesis.It is a common anacronym from the past five years.The implants were marked unavailable implanted which was for all except the bearing which was discarded to allow thorough irrigation of the joint.I do remember this case although it was weeks ago.The depuy prothesis was implanted for revision of a non depuy unicompartmental knee.Our attune primary prosthesis used to revise the uni knee became infected and required intervention with a dair procedure.
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.H10 additional narrative: added: b5.

• Brand Name: ATTUNE RP TIB BASE SZ 9 CEM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 14043771
• Report Number: 1818910-2022-06377
• Device Sequence Number: 5792282
• Product Code: NJL
• UDI-Device Identifier: 10603295492214
• UDI-Public: 10603295492214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/07/2022

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: 1506-80-009
• Device Catalogue Number: 150680009
• Device Lot Number: 9646783
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ 9 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male