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

Catalog Number 151820038

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

An attune patella implant was opened and it appeared to have a manufacturing defect.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an attune patella implant was opened and it appeared to have a manufacturing defect.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo investigation was able to identify what it seems to be a cut from the edge of the device, however since the conditions on which the device was opened remains unknown is not possible to trace this damage to a manufacturing issue, since the device could have been manipulated prior to the photograph.With the information provided is not possible to determine a root cause, however improper handling is suspected.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the [attune medial dome pat 38mm] would not contribute to the complained device issue.  based on the investigation findings, with the information provided is not possible to determine a root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an attune patella implant was opened and it appeared to have a manufacturing defect.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the attune medial dome pat 38mm has a cut on the edge of the device.However, the conditions in which the device was opened are unknown, and it is not possible to attribute this damage to manufacturing error.With the information provided, it is not possible to determine a root cause, however, improper handling is suspected.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune medial dome pat 38mm would not contribute to the complained device issue.Based on the investigation findings, with the information provided is not possible to determine a root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : product code 151820038, work order (b)(4) att medialized dome pat 38mm was manufactured on 02-aug-2023.35 parts were manufactured per specification and all raw materials met specification.Non-conformance: there were no non-conformances associated with this lot.Expiry date: 31-jul-2028.Ifu reference as per bill of material: 090200828 ifu attune fidex bearing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an attune patella implant was opened and it appeared to have a manufacturing defect.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo investigation was able to identify what it seems to be a cut from the edge of the device, however since the conditions on which the device was opened remains unknown is not possible to trace this damage to a manufacturing issue, since the device could have been manipulated prior to the photograph.With the information provided is not possible to determine a root cause, however improper handling is suspected.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the [attune medial dome pat 38mm] would not contribute to the complained device issue.  based on the investigation findings, with the information provided is not possible to determine a root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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).Investigation summary: an attune patella implant was opened and it appeared to have a manufacturing defect.The product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4) device photo (b)(4) 15 nov 2023] the photo investigation was able to identify what it seems to be a cut from the edge of the device, however since the conditions on which the device was opened remains unknown is not possible to trace this damage to a manufacturing issue, since the device could have been manipulated prior to the photograph.With the information provided is not possible to determine a root cause, however improper handling is suspected.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the [attune medial dome pat 38mm] would not contribute to the complained device issue.  based on the investigation findings, with the information provided is not possible to determine a root cause and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18118701
• MDR Text Key: 327912683
• Report Number: 1818910-2023-23033
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056690
• UDI-Public: 10603295056690
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151820038
• Device Lot Number: 4238961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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