MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); Limited Mobility Of The Implanted Joint (2671); 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
The patient's knee was revised to address pain and the doctor noticed swelling in the knee joint with cloudy fluid draining out of the knee.The doctor performed a poly swap on (b)(6) 2020 (b)(4).Surgeon decided to take out all implants and put in an antibiotic static spacer in to remedy the infection before revising at a later date.No surgical delay reported.Doi: (b)(6) 2020 (all other implants) and (b)(6) 2020 (insert), dor: (b)(6) 2020, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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 the poly was swapped on (b)(6) 2020 due to a swollen knee and cloudy secretions.During the procedure, the surgeon noticed that the patella tendon was ruptured and did not have proper quad function.Due to this, as well as the presence of possible infection, the surgeon decided to remove all implants and put in a static antibiotic spacer until the knee can be revised.
Event or Problem Description
1.Product details of unk attune knee tibial insert? -the insert taken out was ref (b)(4) lot 8802388 2.Were there any depuy instrumentation that broke during surgery? if yes, please provide the details.-no instruments were broken during surgery.3.Please clarify if the (b)(6) 2020 revision was due to pain, swelling, wound secretion and infection or was it due to infection only.-originally, the poly was swapped on (b)(6) 2020 due to a swollen knee and cloudy secretions.During this surgery (b)(6) noticed that the patients patella tendon was ruptured and they did not have proper quad function.Due to this as well as the presence of possible infection he decided to remove all implants and put in a static antibiotic spacer until he can revise the knee.I cannot confirm the culture results (infection) because i do not have access to that information.
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.H10 additional narrative: added: b5, g5 and h6 (patient) corrected: h6 (patient) by removing edema and wound secretion.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10656487
• Report Number: 1818910-2020-21852
• Device Sequence Number: 3552273
• Product Code: NJL
• UDI-Device Identifier: 10603295052340
• UDI-Public: 10603295052340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/23/2020

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: 1516-50-414
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL INSERT
• Device Lot Number: 8802388
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/23/2020; 10/05/2020; 11/05/2020; 11/12/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/13/2020; 10/28/2020; 11/06/2020; 11/13/2020
• 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: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE RP TIB BASE SZ 4 CEM; ATTUNE RP TIB BASE SZ 4 CEM; UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE RP TIB BASE SZ 4 CEM; UNK ATTUNE KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 79