MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKNOWN UNIVERSAL 2 IMPL; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after a unknown surgery had been performed, the patient experienced an unknown failure with an unknown universal 2 implant.This adverse event will be solved through a revision surgery.Patient status is unknown.

Manufacturer Narrative

Section h10: 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: as the complaint description does not provide enough information to determine the alleged failure mode, a review of the complaint records for the same product for the alleged hazardous situation/failure mode could not be performed.Risk management review (device): identified no issues which could have caused or contributed to the reported event.As the complaint description does not provide enough information to determine the alleged failure mode, the risk acceptability could not be determined.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 for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond that which has been reported could not be determined.No further clinical assessment can be rendered at this time.Dhr/batch record review: as the product lot number was not reported, the dhr/batch record review could not be completed.- 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 was not returned for evaluation, a determination of whether the device contributed to the reported event could not be made.As the product lot number was not reported, a determination of whether the device met manufacturing specifications could not be made.As the device has not been returned for evaluation, a definitive root cause for the reported event could not be determined.The universal 2 (uni2) wrist total wrist arthroplasty system consists of three sterile implantable components: the radial implant, the carpal plate, and the carpal poly.The radial implant and the carpal plate metal implants are secured in place with screws.The complaint description does not provide enough information to determine the manner in which the device failed and required revision surgery.Therefore, no conclusions about probable or contributing causes could be made.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKNOWN UNIVERSAL 2 IMPL
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 16883083
• MDR Text Key: 314715408
• Report Number: 3002788818-2023-00032
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention