MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-01-206
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of attune cementless cr rp tkr.Revised due to pain & loss of function over time - bone scan showed loosening - more pronounced on tibial side.Revised to attune revision with stems & sleeves - bone sclerotic on tibial side.On removal of primary implants - femur - noted some bone ingrowth on anterior flange & chamfer but not on distal & posterior condyles.Femur was obviously loose.Tibia - did not appear to have bone in growth to porous coating - ? fibrous ingrowth only.Doi: (b)(6) 2021, dor: (b)(6) 2022, unknown knee.
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.
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 indicated that there was no surgical delay.
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.All available x-rays and photographs were reviewed, and due to the lack of series of x rays, there is not possible to see a progression, therefore, no implant loosening can be confirmed.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: ATTUNE FEM POR CR RT SZ 6
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• 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: 14102380
• Report Number: 1818910-2022-06652
• Device Sequence Number: 20027897
• Product Code: MBH
• UDI-Device Identifier: 10603295041498
• UDI-Public: 10603295041498
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 04/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-01-206
• Device Catalogue Number: 150401206
• Device Lot Number: 9614681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 05/12/2022; 06/21/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/04/2022; 05/13/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2020
• 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 CR RP INSRT SZ 6 10MM; ATTUNE FEM POR CR RT SZ 6; ATTUNE RP TIB BASE SZ 6 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 142 KG