MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-206

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 01/08/2021

Event Type  Injury  

Event Description

Attune litigation records received.Patient was revised was due to pain as a result of mechanical loosening, unknown interface.Doi: (b)(6) 2017.Dor: (b)(6) 2021.Right knee.

Manufacturer Narrative

Product complaint # (b)(4) this device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.Initial reporter occupation: lawyer.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.

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.Added: b5, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2017, the patient had a right total knee arthroplasty to address right knee osteoarthritis.Depuy cement, depuy components, including depuy patella were implanted during this procedure.(part/lot page 2082 of 2214).(b)(6) 2018, the patient had right knee manipulation (b)(4).On (b)(6) 2021, the patient had a complete revision of the femoral and tibial components of the right knee to address aseptic loosening, effusions, and pain.The depuy patella was well-fixed and retained and osteophytes were removed from the patella.The tibial tray had debonded from the cement.The femoral component was not grossly loose, but was ¿definitely not as well fixated as (i) would have anticipated¿.The loosening was at the bone/implant interface with fibrinous tissue noted.Depuy components were revised, competitor components and competitor cement was implanted during this procedure.(part/lot page 436 of 2214 (b)(6) medical records ad (b)(6) 2022) on (b)(6) 2021 prior to surgery the patient was noted to have had pain, after a fall.The patient had an incision and drainage with poly exchange to address the assumed infection.During the procedure the surgeon observed medial tibial bone necrosis, a small amount of purulence fluid and osteophytes were removed from the patella.The competitor tibial tray and femoral component were noted to be well-fixed and retained.The competitor insert was revised to another competitor insert.Depuy patella and depuy cement on the patella remained insitu.(b)(4) (sticker sheet page 439 of 2214) see (b)(4).(b)(6) 2021 the patient shows swelling, decreased rom right knee, decreased strength, and pain.(b)(6) 2022 medical records note the patient has muscle weakness, pain in the right knee, decreased rom, stiffness, and swelling in the right knee.

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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2020 the patient was reported to have right knee pain, catching giving way to stiffness, effusion, and swelling.Radiographs are reported to show lucency surrounding the femur and tibial tray.On (b)(6) 2021, the patient had a complete revision of the femoral and tibial component of the right knee to address aseptic loosening of right total knee arthroplasty, pain, and effusion.A preoperative aspiration showed no evidence of infection.During the procedure, the surgeon observed that the cement had loosened from the tibial tray.The femoral component was noted to not be grossly loose, but ¿was definitely not as well fixated as (i) would have anticipated¿ and was removed with fairly minimal effort.There was fibrous tissue noted at the anterior chamber.Depuy components were removed and competitor products were implanted during this procedure.On (b)(6) 2021, the patient had an incision and drainage of the right knee and insertion of antibiotic-loaded cement, tibial insert revision after culture-negative periprosthetic joint infection of the right knee, and pain.The surgeon reported finding medical tibial bone necrosis, a small amount of purulence material, no evidence of sinus tract, and femoral and tibial components were noted to be stable.(competitor component was used during this procedure.(reported in (b)(4).

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 Description

Medical records received.On (b)(6) 2020 medical records note the patient is the status post right total knee arthroplasty, right knee pain, and swelling.It was noted that the patient previously had a diagnostic aspiration on (b)(6) 2020 which was negative for infection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

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.

• Brand Name: ATTUNE CR FEM RT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : 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: 15844275
• MDR Text Key: 304110945
• Report Number: 1818910-2022-23473
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041214
• UDI-Public: 10603295041214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-00-206
• Device Catalogue Number: 150400206
• Device Lot Number: 8514268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CR RP INSRT SZ 6 6MM.; ATTUNE MEDIAL ANAT PAT 35MM.; ATTUNE RP TIB BASE SZ 5 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; UNK ATTUNE KNEE TIBIAL INSERT.; UNK ATTUNE KNEE TIBIAL TRAY.; UNK KNEE FEMORAL ATTUNE REVISION.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR