MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121701052
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pinnacle 100 acet cup 52mm and delta cer insert 36id x 62od were involved in an intraoperative event.During the procedure, the surgeon was dissatisfied with the positioning of the liner and attempted to remove it, which resulted in the cup being unintentionally extracted from the patient.The surgeon proceeded to use a new liner and cup.The procedure was completed successfully, and no fragments were generated.Both the cup and liner were explanted.
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).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.H11 additional narrative: added: b5, d10 concomitant, h6 medical device problem code.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
Additional information received states that the issue happened in a primary case.There are no adverse events known for the patient.Surgery was delayed for about ten minutes as cup was removed, and new implant was implanted.
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 hat 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.H11 additional narrative: added: d9.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.H11 additional narrative: corrected: h6 health effect - impact code.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: according to the information received, it was reported that ¿dr was unhappy with how the liner was sitting and tried to remove it.Unfortunately when he tried to remove it the cup came out of the patient.¿ the product was returned to depuy synthes for evaluation.Visual analysis of the returned device shows that the pinnacle 100 acet cup 52 mm was not properly aligned with the delta cer insert 36id x 62od and cannot be disassembled.No other damage could be observed.With the information provided it is not possible to determine a potential cause at this moment.The misalignment could be during the process of positioning the insert.The pinnacle hip solutions surgical technique, emphasizes the correct technique during insertion, press firmly on handle to introduce the liner into the cup.Do not attempt to fully engage the taper locking mechanism by striking the end of the ab gripper inserter.Carefully remove instrument by pulling back the plastic gripper flange whilst pushing down gently on the gripper handle.Palpate the liner to confirm proper taper alignment and seating in the cup.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the pinnacle 100 acet cup 52 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.Device history lot: a manufacturing record evaluation was performed for the finished device (b)(6) number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Corrected: h3.

• Brand Name: PINNACLE 100 ACET CUP 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24518588
• Report Number: 1818910-2026-04208
• Device Sequence Number: 18250281
• Product Code: LPH
• UDI-Device Identifier: 10603295008552
• UDI-Public: (01)10603295008552(17)350131(10)4738974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121701052
• Device Lot Number: 4738974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/24/2026; 03/26/2026; 04/27/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/16/2026; 03/25/2026; 03/30/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown