MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PIP SZ. 10 PROXIMAL; HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO

Model Number	PIP-200-10P-WW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, a pip arthroplasty had to be revised, on (b)(6) 2023, since the joint dislocated, after being initially operated on (b)(6) 2023.The revision surgery was made with 20p and 20d size implants.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the product has not been returned to the aus site for evaluation and photographs were not provided, so the reported event could not be confirmed.The following investigative actions were performed.Complaint history review: the complaint history review identified similar reported events for this device.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.Dhr/batch record review: identified no issues or manufacturing abnormalities which could have caused or contributed to the reported event.This review determined that the device met manufacturing specifications upon release for distribution.Risk management review (device): identified no issues which could have caused or contributed to the reported event.The failure mode was previously identified by the risk management file and the anticipated risk level is acceptable.Capa/nc/pra/hhe/field action review: identified no previous events or issues which could have caused or contributed to the reported event.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Device labeling/ifu review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met labeling requirements upon release for distribution.Product prints/specifications/procedure review: identified no issues which could have caused or contributed to the reported event.This review determined that the device met product specifications upon release for distribution.Clinical/medical evaluation: the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Therefore, the impact to the patient beyond the reported joint dislocation and subsequent revision could not be confirmed nor concluded.Visual inspection: visual inspection was unable to be performed because the device has not been received for evaluation.The complaint alleges that revision surgery was required.As the device has not been returned for evaluation, it could not be determined whether the device contributed to the reported event.As the device has not been returned for evaluation, a definitive root cause could not be determined.The pip arthroplasty system consists of two implantable pyrocarbon components: the proximal implant and the distal implant.The complaint alleges that the patient was implanted with size 10 implants and that the patient¿s joint dislocated several days after the primary surgery.The complaint indicates that revision surgery was required and that the size 10 implants were replaced with size 20 components.According to risk documentation for the pip system, the potential causes for the reported event include incorrect size selection, incorrect surgical technique, and inappropriate handling/activity post-implantation.Based on this investigation, the need for corrective action is not indicated as no non-conformances nor manufacturing deficiencies were identified and the risk level is acceptable.If additional information is later received, the complaint may be reopened.No further investigation is warranted for this complaint, though future complaints will be monitored and investigated as required.This investigation can be closed.

• Brand Name: PIP SZ. 10 PROXIMAL
• Common Device Name: HIGH DEMAND, REVISION, SEMI-CONSTRAINED, PYROLYTIC CARBON, UNCEMENTED FINGER PRO
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16889706
• Report Number: 3002788818-2023-00035
• Device Sequence Number: 6140080
• Product Code: OMX
• UDI-Device Identifier: 00885556858400
• UDI-Public: 00885556858400
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: H010005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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 Expiration Date: 07/31/2024
• Device Model Number: PIP-200-10P-WW
• Device Catalogue Number: PIP-200-10P-WW
• Device Lot Number: 202868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown