MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN PIP IMPL; HIGH DEMAND, REVISION, SEMI-CONSTR, PYROLYTIC CARBON, UNCEMEN FINGER PROSTH

Catalog Number UNKN2400503

Device Problem Migration (4003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/04/2020

Event Type  Injury  

Event Description

It was reported that on literature review "outcome of proximal interphalangeal joint replacement with pyrocarbon implants: a long-term longitudinal follow-up study", twenty five (25) patients received a pip joint replacement with a pyrocarbon prosthesis.From this cohort, fifteen (15) patients with eighteen (18) pip replacements who were followed up at a minimum of 9 postoperative years were assessed for implant migration according to the nelson hospital and sweets & sterns radiographic scoring system (both described within the paper).The results revealed that thirteen (13) prosthesis showed an angulation of the implant with contact to the cortex graded as level two according to the nelson hospital scoring scale.From these joint prosthesis, ten (10) replacements partially eroded through the cortex of the bone.None of these prosthesis perforated the cortex and no implant fracture was detected.According to the sweets & sterns score, ten (10) prosthesis showed severe migration.The number of prosthesis that presented a degree of migration associated to each scoring system are not mutually exclusive; therefore, the exact number of migrated prosthesis is unclear.Additional details regarding the final outcome of these patients are unknown.No further information is available.

Manufacturer Narrative

Literature citation: outcome of proximal interphalangeal joint replacement with pyrocarbon implants: a long-term longitudinal follow-up study.Doi: https://doi.Org/10.1007/s00402-020-03592-3.Archives of orthopaedic and trauma surgery (2020) 140:1847¿1857 (2020).Initial/final mdr.Internal reference: (b)(4).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.

• Brand Name: UNKN PIP IMPL
• Type of Device: HIGH DEMAND, REVISION, SEMI-CONSTR, PYROLYTIC CARBON, UNCEMEN FINGER PROSTH
• 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: 15844122
• MDR Text Key: 304108786
• Report Number: 3002788818-2022-00106
• Device Sequence Number: 1
• Product Code: OMX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN2400503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/22/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention