MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 40MM IMPLANT TO TRIAL ADAPTER; HIP INSTRUMENTS : ADAPTORS

Catalog Number	298740040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while overlooking instruments before entering facility spd process, it was noticed that three segmental component trials do not match the other trials in the set.The three affected seem to be different because the segments do not have a locking ring.
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) investigation summary as per the note a-13620596 does not meet the definition of a complaint.Information has been reviewed and determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a j&j medtech orthopedics device after it was released for distribution.There is no report of an adverse event involving a j&j medtech orthopedics device.

• Brand Name: 40MM IMPLANT TO TRIAL ADAPTER
• Common Device Name: HIP INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22781608
• Report Number: 1818910-2025-14008
• Device Sequence Number: 13228816
• Product Code: HWT
• UDI-Device Identifier: 10603295158752
• UDI-Public: (01)10603295158752(10)AB4715375
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup

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: 298740040
• Device Lot Number: AB4715375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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