MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-038

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A-8391593 - (b)(6) 2022 (b)(4) clinical notes ad (b)(6) 2022 and (b)(4) clinical notes ad (b)(6) 2022 (2) were reviewed by a clinician on (b)(6) 2022.(b)(6) 2022: patient returns to the office for follow-up after left knee revision.The surgeon states she was previously revised for aseptic loosening of the tibia and patella (captured on (b)(4).Post revision, she now has pain, stiffness, and swelling.She appears to have a dysvascular patella with breakdown.She has a large effusion and tenderness over the anterior knee consistent with patellar tendinitis.She has palpable fragmentation of the patella.70ml of bloody fluid was aspirated to ¿reduce some of the burden.¿ (b)(6) 2022: clinic visit states the patient has an avascular patella.The patellar button has now dislocated and is floating in the suprapatellar pouch.In the near future, the surgeon plans to make a limited arthrotomy and remove the button with a kocher so that the extensor mechanism is not disturbed.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 Description

Clinical adverse event received for devascularizing patella.Abnormal radiographic evaluation.Free floating patellar button due to avascularized patella.Event is not serious and is considered mild.Event is definitely not related to device and is possibly related to procedure.Date of implant: (b)(6) 2020.Date of event: (b)(6) 2021.Left knee treatment: none.

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

Event Description

Additional information received.The clinical database indicates the adverse event is serious.The clinical database also identifies "arthrotomy with excision of patellar component" as a treatment for the free floating patellar button due to avascularized patella.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation cannot confirm the reported allegation.However the device can be seen separated from the patella with the cement still on the device and the void on the patella where the device should be can be noticed.This indicates the device is well fixed to the cement, but the cement is not fixed to the patella.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.A-8391593 - dec 12 2022 (b)(4) clinical notes ad 07 dec 2022 and (b)(4) clinical notes ad 07 dec 2022 (2) were reviewed by a clinician on 12-dec-2022.20-oct-2022: patient returns to the office for follow-up after left knee revision.The surgeon states she was previously revised for aseptic loosening of the tibia and patella (captured on (b)(4)).Post revision, she now has pain, stiffness, and swelling.She appears to have a dysvascular patella with breakdown.She has a large effusion and tenderness over the anterior knee consistent with patellar tendinitis.She has palpable fragmentation of the patella.70ml of bloody fluid was aspirated to ¿reduce some of the burden.¿ (b)(6) 2022: clinic visit states the patient has an avascular patella.The patellar button has now dislocated and is floating in the suprapatellar pouch.In the near future, the surgeon plans to make a limited arthrotomy and remove the button with a kocher so that the extensor mechanism is not disturbed.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).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation cannot confirm the reported allegation.However the device can be seen separated from the patella with the cement still on the device and the void on the patella where the device should be can be noticed.This indicates the device is well fixed to the cement, but the cement is not fixed to the patella.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATTUNE MEDIAL DOME PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16003273
• MDR Text Key: 305684505
• Report Number: 1818910-2022-25688
• Device Sequence Number: 1
• Product Code: JWH
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1518-20-038
• Device Catalogue Number: 151820038
• Device Lot Number: 9410109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• 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 MEDIAL DOME PAT 38MM; ATTUNE PS RP INSRT SZ 5 10MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET WITH GENTAMICIN 40G; UNK KNEE FEMORAL ATTUNE
• Patient Outcome(s): Required Intervention