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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 02/15/2006

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Tuttle, h.G., & stern, p.J.(2006).Pyrolytic carbon proximal interphalangeal joint resurfacing arthroplasty.The journal of hand surgery, 31(6), 930-939.Doi: 10.1016/j.Jhsa.2006.02.018.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.

Event Description

It was reported that on literature review " pyrolytic carbon proximal interphalangeal joint resurfacing arthroplasty ", four (4) patients had coronal plane deformity after a proximal interphalangeal (pip) joint arthroplasty procedure using a pyrolytic carbon implant from smith and nephew.Two of these 4 joints had the proximal phalanx components placed in an angulated configuration (12°, 15°) and two (2) joints had the middle phalanx component angulated (both 15°).The angulation of these four (4) joints did not appear to change over the study period.It was believed that deformity in the coronal plane likely was preventable and was a result of a less-than-perfect technique during the broaching process.The patients believe these fingers had an improved appearance after surgery.No further information is available.

• Brand Name: PIP IMPL
• 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: 15969577
• MDR Text Key: 305359255
• Report Number: 3002788818-2022-00176
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 12/12/2022
• 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): Other