MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 RECLAIMTM; PROSTHESIS, HIP

Catalog Number	101654018
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	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that item arrived damaged.Plastic shrink wrap torn.
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.H11 additional narrative: d2a: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented.H3, h6: a manufacturing record evaluation was performed for the finished device (b)(4) lot number, and no non-conformances nor manufacturing irregularities were identified.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found one portion of the plastic cover/outer packaging ripped off.No additional damage was identified on the evidence provided.Condition observed on the outer packaging suggest that it may had suffered from improper storage and/or manipulation, subsequently to the manufacturing packaging process.Therefore, no evidence suggests an error in the manufacturing that could be a contributing factor in the reported allegation.Once the product leaves depuy synthes control, it is unknown what environmental/external factors the finished goods products are exposed to; therefore, the suspected cause is traced to transport/storage.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 mono short stem 18 so would have contributed to the complained device issue.Based on the investigation findings, 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.

• Brand Name: RECLAIMTM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25622807
• Report Number: 1818910-2026-10870
• Device Sequence Number: 21361225
• Product Code: LZO
• UDI-Device Identifier: 10603295554226
• UDI-Public: (01)10603295554226(17)351130(10)4983922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K251292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 101654018
• Device Lot Number: 4983922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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