MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-906
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/30/2015
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
Legal medical records received jan 8, 2018.Right total knee replacement from (b)(6) 2014 (a revision of a competitor unicompartmental arthroplasty) was in turn revised (b)(6) 2017 for pain, recurrent effusions, and poor range of motion of 10-80 degrees.Revising surgeon identified that the tibial baseplate component was internally malrotated approximately 10-15 degrees.There was also noted premature polyethylene wear of the far posterior medial aspect of the tibial insert.Surgeon also indicated that the patella component was undersized, with about 12 mm of lateral native patella bone uncovered and making contact with the femur component.Femur, tibial baseplate and patella implant components were all well-fixed.All products were revised.Doi: (b)(6) 2014.Dor: (b)(6) 2017, right knee.
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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: udi: (b)(4).Added: patient identifier, date of event, description of event or problem, other relevant history and evaluation codes (patient) no code available was used to capture medical device removal and surgical intervention.Corrected: explant date and evaluation codes (patient).
Event or Problem Description
Corrected code for swelling and decreased joint range of motion.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  added: b7, d11, h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ATTUNE PS FB INSRT SZ 9 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7227494
• Report Number: 1818910-2018-52369
• Device Sequence Number: 997971
• Product Code: JWH
• UDI-Device Identifier: 10603295050490
• UDI-Public: 10603295050490
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/08/2018

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 Expiration Date: 04/30/2018
• Device Model Number: 1516-40-906
• Device Catalogue Number: 151640906
• Device Lot Number: 367192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 12/09/2019; 03/10/2020; 05/20/2020
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 11/28/2018; 12/20/2019; 03/23/2020; 05/21/2020
• 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 FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 9 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR