MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121720050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2011, the primary surgery was performed.After the surgery, the dislocation was confirmed.The event date is unknown.The revision surgery was performed on (b)(6) 2016, to replace the liner, the head and the stem.After the revision surgery, the liner in question was broken.The event date is unknown.The revision surgery is scheduled on (b)(6) 2023, to replace the cup, the head and the stem in question.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Investigation summary = > this pc is related to (b)(4) which reports dislocation after the primary surgery.This pc reports the breakage of the liner after the revision surgery.It was reported that on (b)(6) 2011, the primary surgery was performed.After the surgery, the dislocation was confirmed.The event date is unknown.The revision surgery was performed on (b)(6) 2016, to replace the liner, the head and the stem.After the revision surgery, the liner in question was broken.The event date is unknown.The revision surgery is scheduled on (b)(6) 2023, to replace the cup, the head and the stem in question.No further information is available.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the pinnacle multihole ii cup 50mm has signs of organic material adhered to the outer fixation surface.Additionally signs of metal wear were observed at the articulating surface most likely caused by being in contact with the femoral head after a disassociation event occurred.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the cup failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device 121720050/fk9dl1 number, and no non-conformances / manufacturing irregularities were identified during manufacturing.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinnacle multihole ii cup 50mm would have contributed to the reported adverse event.Based on the investigation findings, a definitive conclusive potential cause could not be established, 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 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 = > 1) quantity manufactured: (b)(4).2) date of manufacture: 03-30-2011 3) any anomalies or deviations identified in dhr: none 4) expiry date: 03-2021 5) ifu reference: 090200828 device history batch = > null device history review = > 1) quantity manufactured: (b)(4).2) date of manufacture: 03-30-2011 3) any anomalies or deviations identified in dhr: none 4) expiry date: 03-2021 5) ifu reference: 090200828.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.

• Brand Name: PINNACLE MULTIHOLE II CUP 50MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20273027
• Report Number: 1818910-2024-19876
• Device Sequence Number: 15282676
• Product Code: LPH
• UDI-Device Identifier: 10603295009610
• UDI-Public: (01)10603295009610(10)FK9DL1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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
• Report Date (Section B): 09/20/2024

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: 121720050
• Device Lot Number: FK9DL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2011
• 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