MAUDE Adverse Event Report: DePuy Orthopaedics Inc US APEX; Pinnacle Hip System : Hip Acetabular Augment

Catalog Number	124603000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unspecified surgery using the apex hole elim positive stop product.After the pinnacle cup was placed, the surgeon attempted to install the product, which locked up midway and could not be fully tightened.The surgery proceeded without use of the product.The surgery was completed successfully without delay.All available information has been disclosed.
Additional Manufacturer Narrative
Product complaint # (b)(4) depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APEX
• Common Device Name: Pinnacle Hip System : Hip Acetabular Augment
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50731119
• Report Number: 1818910-2026-15567
• Device Sequence Number: 10591855
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: (01)10603295019688(17)351231(10)D26011037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2026

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: 124603000
• Device Lot Number: D26011037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/15/2026; 09/23/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/21/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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