MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-207

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 a manufacturing defect was found on an attune femoral component implant prior to implantation.The implant was not implanted and did not come in contact with the patient in any way.It is also reported that the implant was removed from the sterile field and replaced with another satisfactory one form implantation.No report of harm or delay.Doe: (b)(6) 2021, 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: added: d4 (lot) and d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1 and h3.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned device confirmed the presence of excess material on the lateral notch adjacent to the lug, where the femoral introducer grips onto the implant.(b)(4) has been opened for this nonconformance.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: product code 150400207, work order (b)(4), was manufactured on 29 sep 2020.- (b)(4) parts were manufactured per specification, and all raw material met specification.- there was one scrap part found to be associated with work order (b)(4): a628 - ap undersize anterior ¿ this scrap reason does not correlate with the failure mode for this complaint - there is one non-conformances (nc) found to be associated with work order (b)(4): (b)(4) relates to a snap gauge failing calibration.Therefore, there is no correlation between (b)(4) and the failure mode for this complaint.- there was no reprocessing associated with work order (b)(4).- the finished goods femoral work order (b)(4) was issued from foundry work orders ((b)(4)).- from a review of the laser mark on the complaint unit (figure 10), it was confirmed that the part originated from work order (b)(4) - product code 150400407, work order (b)(4), was manufactured on 15 sep 2020.- (b)(4) out of (b)(4) parts were manufactured per specification, and all raw material met specification for work order (b)(4).- there were two scrap parts found to be associated with work order (b)(4): a272 ¿ grinding damage (post cast) ¿ this scrap reason does not correlate with the failure mode for this complaint.A276 ¿ ceramic defects (post cast) ¿ this scrap reason does not correlate with the failure mode for this complaint.- there are two non-conformances (nc) found to be associated with work order (b)(4) : (b)(4) relates to a label scanning issue.Therefore, there is no correlation between (b)(4) and the failure mode for this complaint.(b)(4) relates to a laser mark issue.Therefore, there is no correlation between (b)(4) and the failure mode for this complaint.- there was no reprocessing associated with work order (b)(4).- foundry work order (b)(4) was issued into two different femoral work orders (b)(4) (review covered above) and (b)(4) - product code 150400207, work order (b)(4), was manufactured on 13 oct 2020.- (b)(4) parts were manufactured per specification, and all raw material met specification for work order (b)(4).- there were zero scrap parts found to be associated with work order (b)(4).- there is one non-conformances (nc) found to be associated with work order (b)(4) : (b)(4) relates to a snap gauge failing calibration.Therefore, there is no correlation between (b)(4) and the failure mode for this complaint.- there were (b)(4) reprocessed parts found to be associated with work order (b)(4): impact damage ¿ this rework reason does not correlate with the failure mode of this complaint.Corrected: h3.

• Brand Name: ATTUNE CR FEM RT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11434737
• MDR Text Key: 244050102
• Report Number: 1818910-2021-04561
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041221
• UDI-Public: 10603295041221
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-00-207
• Device Catalogue Number: 150400207
• Device Lot Number: 9595588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78