MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-10-006
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
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.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.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
¿voluntary report received (mw5113219) patient stated: i had arthritis and saw an orthopedic surgeon.He implanted an attune l knee prothesis.From day 1 i had problems.Severe pain; swelling and even the physical therapist relayed symptoms unusual.I finally had ct done and it showed debonding of prothesis and the original surgeon relayed he does not do revisions i finally found an excellent ortho doctor w/ (b)(6), and he saw results of ct and he replaced the attune device w/ a stryker device.But in interim of follow up from 1st surgery implant of attune device, i had additional surgery for left knee neuroma; then still had issues and swelling.Recently i had the peroneal nerve left knee decompressed by same surgeon who did the revision: dr.(b)(6).The original surgeon and his colleague he sent me to treat me as a hysterical female.Ps i am an rn in my 60's so i know my body very well, and i knew the severe pain i was feeling was not normal.Even dr.(b)(6), the original surgeon, his own therapist had admitted to met the pain and symptoms i was having were very abnormal.".

• Brand Name: ATTUNE RP TIB BASE SZ 6 CEM
• Common Device Name: ATTUNE IMPLANT : 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15940815
• Report Number: 1818910-2022-24735
• Device Sequence Number: 17706771
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: 10603295042600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: 1506-10-006
• Device Catalogue Number: 150610006
• Device Lot Number: 8466836
• 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: 11/18/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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 38MM.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; UNK ATTUNE KNEE TIBIAL INSERT.; UNKNOWN KNEE FEMORAL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown