MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS LNR AOX ELV 64-66X36; HIP IMPLANT : ACETABULAR LINER

Catalog Number	472264236
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the packaging on this emphasys liner has a pink color code which is for the 40 liners.The part number and description say this liner is a 36.
Additional 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.
Additional 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 that 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.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.Corrected: b3.
Event or Problem Description
Additional information was received and stated that this was discovered in the office on october 23rd.No surgery was involved.Also stated that the product can be returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Product code 472264236, work order (b)(4) was manufactured on 11-sep-2023 30 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot prior to the completion of this dhr review task however on review of the physical dhr (see figure 2) and associated master label in comparison with the labelling specification for this product code 103681340, lcn-4722-64-236_1, rev.C (see figure 3) the incorrect color coding on the outer carton label was confirmed and nr-0210075 was initiated to further investigate & bound this issue.Complaint confirmation: confirmed.Conclusion: due to similar failure found in the dhr review, this complaint is confirmed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a review was completed of the device history record (dhr) for the following: product code 472264236, work order (b)(4) was manufactured on 11-sep-2023 30 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot prior to the completion of this dhr review task however on review of the physical dhr (see figure 2) and associated master label in comparison with the labelling specification for this product code 103681340, lcn-4722-64-236_1, rev.C (see figure 3) the incorrect color coding on the outer carton label was confirmed and nr-0210075 was initiated to further investigate & bound this issue.

• Brand Name: EMSYS LNR AOX ELV 64-66X36
• Common Device Name: HIP IMPLANT : ACETABULAR LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18030484
• Report Number: 1818910-2023-21941
• Device Sequence Number: 12277123
• Product Code: LPH
• UDI-Device Identifier: 10603295500322
• UDI-Public: 10603295500322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 472264236
• Device Lot Number: 4281117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 12/26/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/08/2023; 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown