MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPER CEM STEM 13X150MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	866499
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the incorrect label was on the box.
Event or Problem Description
Additional information received: a.Was/were there any adverse consequence/s that affected the patient because of the reported event? - no, it was discovered during inventory management.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: wrong label or-code, wrong qr -code, label : art: 86-6499 13x 150 cemented stem lot d 16122525, qr -code as well ean code says 15 x 150 cemented stem, notice when i was cycle account.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 taper cem stem 13x150mm box was found in good condition, and the labeling on the package is correct.However, the problem was identified as a data error within the esims system.This product issue will be addressed through depuy synthes quality system.A dimensional inspection was unable to be 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 confirmed as the observed condition of the taper cem stem 13x150mm would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 04-feb-2017.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 31-jan-2027.5) ifu reference: ifu-0902-00-252 h3.

• Brand Name: TAPER CEM STEM 13X150MM
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18606232
• Report Number: 1818910-2024-02005
• Device Sequence Number: 18430327
• Product Code: JWH
• UDI-Device Identifier: 10603295217206
• UDI-Public: 10603295217206
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2024

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: 866499
• Device Lot Number: D16122525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/31/2024; 03/11/2024; 05/27/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 01/31/2024; 03/13/2024; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2017
• 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