MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 46MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121720046
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised on (b)(6) 2022 for unknown reason, and later re-revised on (b)(6) 2023, where the head and insert were replaced due to metallosis.No surgical delay reported.
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.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.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 that 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).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 : according to the information received, description: 1.Surgery with novelty since reference cup implant * batch * is removed, acetabular screws length 20 ref * lot *, acetabular screw length 25 ref * lot *, reference insert * lot *, ceramic head reference * lot *, this patient has had several interventions the cup was placed on (date of implantation removed) and was re-operated where the insect and head are placed on the day (date of re-intervention) and today the reintervention is done again because the material generated metallosis and the decision is made to place the cemented cup and the disc insert and head 222,225 +7 johnson , the extracted material is left for study and delivered to the stock manager and the head of centra, photo evidence is sent.The product was not returned to depuy synthes, however photos were provided for review.See attachment sabana chía - 455735- de pérez - pt maría mery vargas pinzon.The photo investigation revealed that the pinnacle bantam acet cup 46mm exhibits a broken condition on one side.The broken fragment was not returned for examination.Also noticeable on the edges of the broken area is a reduction in the internal surface of the cup.It is reasonable to conclude that this was due to wear in that area first, followed by the break.This was caused by the anti rotational devices on the liner being observed detached from the edge, causing a dissociation between the liner and the cup.Additionally, we can conclude that the wear condition in the broken area of the cup was due to the unintended articulation of the head and the cup.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the pinnacle bantam acet cup 46mm may have been caused by exposure to irregularities in the weight loading of the device and moments generated.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the cup 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 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 j7365x/121720046 number, and no non-conformances /manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : description: 1.Surgery with novelty since reference cup implant * batch * is removed, acetabular screws length 20 ref * lot *, acetabular screw length 25 ref * lot *, reference insert * lot *, ceramic head reference * lot *, this patient has had several interventions the cup was placed on (date of implantation removed) and was re-operated where the insect and head are placed on the day (date of re-intervention) and today the reintervention is done again because the material generated metallosis and the decision is made to place the cemented cup and the disc insert and head 222,225 +7 johnson , the extracted material is left for study and delivered to the stock manager and the head of centra, photo evidence is sent.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 bantam acet cup 46mm exhibits a broken condition on one side.The broken fragment was not returned for examination.Also noticeable on the edges of the broken area is a reduction in the internal surface of the cup.It is reasonable to conclude that this was due to wear in that area first, followed by the break.This was caused by the anti rotational devices on the liner being observed detached from the edge, causing a dissociation between the liner and the cup.Additionally, we can conclude that the wear condition in the broken area of the cup was due to the unintended articulation of the head and the cup.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the pinnacle bantam acet cup 46mm may have been caused by exposure to irregularities in the weight loading of the device and moments generated.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.A functional test was not performed as it is not applicable to the complaint condition.A dimensional inspection was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pinnacle bantam acet cup 46mm would contribute 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 122136054/m37m38 number, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: PINNACLE BANTAM ACET CUP 46MM
• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18637083
• Report Number: 1818910-2024-02290
• Device Sequence Number: 7762954
• Product Code: LPH
• UDI-Device Identifier: 10603295009597
• UDI-Public: 10603295009597
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/02/2024

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: 121720046
• Device Lot Number: J7365X
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 02/01/2024; 02/07/2024; 02/13/2024; 04/04/2024; 04/24/2024; 04/25/2024
• Initial Report FDA Received Date: 02/03/2024
• Supplement Report FDA Received Date: 02/06/2024; 02/13/2024; 02/15/2024; 04/05/2024; 04/25/2024; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MAR +4 10D 28IDX46OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female