MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932148
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was operated with corail - pinnacle poly on metal system in (b)(6) 2021 and in (b)(6) 2023 because of squeaking in hip joint the patient visited hcp.After additional x-ray it was observed that the head is articulating in pinnacle cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "the patient was operated with corail - pinnacle poly on metal system in may 2021 and in august 2023 because of squaking in hip joint the patient visited hcp.After additional x-ray it was observed that the head is articulating in pinnacle cup." the device associated with this report was not returned to depuy synthes for evaluation.The product was not returned to depuy synthes, however photos were provided for review.See attachment (complaint1-complaint6).The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: the patient was operated with corail - pinnacle poly on metal system on (b)(6) 2021 and on (b)(6) 2023 because of squawking in hip joint the patient visited hcp.After additional x-ray it was observed that the head is articulating in pinnacle cup.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The visual inspection of the returned sample revealed that the pinn mar +4 10d 32idx48od was observed fractured, the five anti rotations have been sheared off.Also the liner present deformation.The broken fragments were not returned for examination.Based on the observed damage on the liner and the internal wear on only one side, it is reasonable to conclude that the liner disassociated from the cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.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 dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 32idx48od would contribute to the complained device issue.Based on the investigation findings 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 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: product description: pinn mar +4 10d 32idx48od.Product code: 121932148.Lot number: j93j09.A manufacturing record evaluation was performed for the finished device lot: j93j09/product code: 121932148, and no non-conformance's /manufacturing irregularities were identified.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN MAR +4 10D 32IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17612527
• Report Number: 1818910-2023-17487
• Device Sequence Number: 17991895
• Product Code: LPH
• UDI-Device Identifier: 10603295014034
• UDI-Public: 10603295014034
• Combination Product (Y/N): N
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 08/24/2023

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: 121932148
• Device Lot Number: J93J09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 02/12/2024; 03/12/2024
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 08/27/2023; 02/14/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2020
• 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: ARTICUL/EZE BALL 32 +1 GR.; PINN SECTOR W/GRIPTION 48MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female