MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 6 POR; KNEE IMPLANT - TIBIAL TRAY

Catalog Number 150621006

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Wrong Label (4073)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).B3: date of event is an unknown date.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

Size 6 affixium box had a size 8 affixium sticker.Implant was implanted and was a size 6.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received: size 6 affixium box had a size 8 affixium sticker.Implant was implanted and was a size 6.The product was not returned to depuy synthese, however photos were provided for review.The photo investigation revealed an opened package of attune fb tib base sz 6 por with a different patient label information attached, regarding lot number and product code.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 6 por would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the photo evidence received.This product issue will be addressed through depuy synthese quality system.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 issue.

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: h7 and h9.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 according to the information received: size 6 affixium box had a size 8 affixium sticker.Implant was implanted and was a size 6.The product was not returned to depuy synthes, however photos were provided for review.See attachment (image.Jpg).The photo investigation revealed an opened package of attune fb tib base sz 6 por with a different patient label information attached, regarding lot number and product code.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 6 por would contribute to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the photo evidence received.This product issue will be addressed through depuy synthes quality system.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 issue.

• Brand Name: ATTUNE FB TIB BASE SZ 6 POR
• Type of Device: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18382709
• MDR Text Key: 331192577
• Report Number: 1818910-2023-25865
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295507451
• UDI-Public: 10603295507451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213781
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150621006
• Device Lot Number: JA06A0252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/29/2024; 04/16/2024; 04/17/2024; 05/02/2024
• Supplement Dates FDA Received: 01/30/2024; 04/16/2024; 04/18/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1818910-03/05/2024-001-R
• Patient Sequence Number: 1