MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 RECLAIM MON REV LNG STEM 16 SO; HIP FEMORAL STEM

Catalog Number	102354016
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both the exterior and interior packaging was damaged.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the delivery service issue for product damage.Replacement was needed for the damaged products outlined below.Both the exterior and interior packaging was damaged.The device associated with this report was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and photo evidence was reviewed from attachment (b)(4).Visual analysis of the returned device found that the outer cardboard box was severely damaged at the lid and was opened, the shrink-wrap plastic was torn, the inner pouch was partially opened in certain parts.Additionally at the photo attached the kraft box used to shipped the implants was damaged too.The potential cause of the observed complaint condition cannot be traced to a manufacturing issue.Once the product leaves depuy synthes control, it is unknown what environment conditions or human intervention or manipulation the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim mon rev lng stem 16 so would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage 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 : a manufacturing record evaluation was performed for the finished device [102354016/4305910] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review : a manufacturing record evaluation was performed for the finished device [102354016/4305910] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: RECLAIM MON REV LNG STEM 16 SO
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19160209
• Report Number: 1818910-2024-08683
• Device Sequence Number: 12750039
• Product Code: LZO
• UDI-Device Identifier: 10603295533887
• UDI-Public: (01)10603295533887(17)330930(10)4305910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2024

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: 102354016
• Device Lot Number: 4305910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 08/08/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/21/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown