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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA
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DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA Back to Search Results
Model Number 1518-20-041
Device Problems Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 Description
It was reported that the inside of patella packaging was compromised.The top lid did not peel completely and circulating nurse questioned sterility.This product was not implanted.This happened during primary knee, not a revision surgery.No delay to surgery reported.
 
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
Additional information received indicated that there were no adverse consequences that affected the patient because of the reported event.
 
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device/packaging components confirmed the integrity of the blister seal appeared compromised, however the seal of in inner pouch packaging remained intact, therefore sterility of the product was not breached.Based on the complaint investigation, there is no impact on the sterility of the unit or the integrity of sterile barrier.The analysis of this device does not highlighted any manufacturing related defect and the need of corrective actions is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a review was completed of the device history record (dhr) and operations management system (oms) for the following: - product code 151820041, work order (b)(4) was manufactured on 23-feb-2021.- all raw materials met specification.- 35 parts were manufactured to specification.- there was no scrap associated with this lot.- there were no non-conformances associated with this lot.- there was no material reprocessing reports (mrr) associated with this lot.Corrected: h3.
 
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Brand Name
ATTUNE MEDIAL DOME PAT 41MM
Type of Device
ATTUNE IMPLANT : KNEE PATELLA
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11859928
MDR Text Key251986025
Report Number1818910-2021-10872
Device Sequence Number1
Product Code OIY
UDI-Device Identifier10603295056706
UDI-Public10603295056706
Combination Product (y/n)N
PMA/PMN Number
P830055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1518-20-041
Device Catalogue Number151820041
Device Lot Number9714655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
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