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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2011

Event Type  Injury  

Event Description

It was reported that on literature review ¿pyrocarbon proximal interphalangeal joint arthroplasty: outcomes of a cohort study ", five (5) joints required revision after a proximal interphalangeal (pip) joint arthroplasty procedure using a pyrolytic carbon implant from smith and nephew.One (1) joint required revision for impending cut-out of the proximal component due to angular subsidence.The proximal component was revised to a larger pyrocarbon component.The patient did well and had a pain free arc of motion of 75° at the final follow-up.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Mcguire, d.T., white, c.D., carter, s.L., & solomons, m.W.(2012).Pyrocarbon proximal interphalangeal joint arthroplasty: outcomes of a cohort study.Journal of hand surgery (european volume), 37(6), 490-496.Doi: 10.1177/1753193411434053.This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Manufacturer Narrative

Corrected data: h6 (health effect - clinical code, type of investigation).Results of investigation: the product has not been received at the aus site for evaluation and photographs were not provided, so the complaint could not be confirmed.The following investigative actions were performed.- complaint history review: the complaint history review identified similar reported events for this product family.No adverse trend was identified.Future complaints for this failure mode will continue to be monitored and investigated as required.- 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: patient-specific supporting documentation was not provided, so a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The complaint alleges that revision surgery was required.As no products have been received for evaluation, it could not be determined whether the device contributed to the reported events.As the product lot numbers were not reported, it could not be determined whether the devices met manufacturing specifications.According to risk management documentation for pip implants, potential causes for the reported event include incorrect surgical technique, incorrect size or patient selection, and improper post-surgical activity.Based on this investigation, the need for corrective action is not indicated as no non-conformances or 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 IMPLANT
• Type of Device: 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: 16014873
• MDR Text Key: 305813418
• Report Number: 3002788818-2022-00183
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 02/10/2023
• 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; Hospitalization