MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; HIP ACETABULAR CUP

Catalog Number	121722056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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
It was reported that the an ard broke off and was found during the revision.Surgery delay : no; revision surgery : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinnacle sector ii cup 56mm was found with dissociation with the liner, and it can be observed in the cup the evidence of material transfer between the cup and the ceramic head.A definitive root cause can not be determined with the information provided.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 56mm would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be determined, 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): quantity manufactured: 40 parts were manufactured per met specification.2) date of manufacture: 05/11/2023 3) any anomalies or deviations identified in dhr: no 4) expiry date: 30 / april / 2033.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that pinnacle sector ii cup 56mm was found with dissociation with the liner, and it can be observed in the cup the evidence of material transfer between the cup and the ceramic head.A definitive root cause can not be determined with the information provided.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 56mm would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be determined, 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) parts were manufactured per met specification.2) date of manufacture: 05/11/2023.3) any anomalies or deviations identified in dhr: no.4) expiry date: 30 / april / 2033.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the pinnacle sector ii cup 56mm showed evidence of the disassociation between the liner and cup in the form of material transfer between the cup and the ceramic head after the liner separated 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.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 56mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is not established, however, there is no indication that a design or manufacturing issue has caused or contributed to the complaint condition.No corrective and/or preventative action is proposed.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) parts were manufactured per met specification.2) date of manufacture: 05/11/2023.3) any anomalies or deviations identified in dhr: no.4) expiry date: 30 / april / 2033.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that ard¿s have fractured off, one fractured ard was found during revision the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the pinnacle sector ii cup 56mm showed evidence of the disassociation between the liner and cup in the form of material transfer between the cup and the ceramic head after the liner separated 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.¿the overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 56mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure.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: 40 parts were manufactured per met specification.2) date of manufacture: 05/11/2023 3) any anomalies or deviations identified in dhr: no 4) expiry date: 30 / april / 2033.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• Common Device Name: HIP ACETABULAR CUP
• 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: 18140391
• Report Number: 1818910-2023-23285
• Device Sequence Number: 15465180
• Product Code: LPH
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (Y/N): N
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 11/15/2023

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: 121722056
• Device Lot Number: M36T19
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 11/24/2023; 01/18/2024; 01/18/2024; 01/30/2024; 01/31/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 11/27/2023; 01/19/2024; 01/22/2024; 01/30/2024; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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: PINN MAR NEUT 36IDX56OD; UNK HIP FEMORAL HEAD CERAMIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown