MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM; UNI2 TOTAL WRIST IMPLANT SYSTEM

Catalog Number XXX-UNI2

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

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

1 of 2 reports.Other mfg report number: 1651501-2022-00003.The bone & joint journal (2016) published ¿medium-term outcomes of the universal-2 total wrist arthroplasty in patients with rheumatoid arthritis¿ aims: ¿the aims of this study were to evaluate the clinical and radiological outcomes of the universal-2 total wrist arthroplasty (twa) in patients with rheumatoid arthritis.¿ patients and methods: ¿this was a retrospective review of all 95 universal-2 twas which were performed in our institution between 2003 to 2012 in patients with rheumatoid arthritis.A total of six patients were lost to follow-up and two died of unrelated causes.A total of ten patients had bilateral procedures.Accordingly, 75 patients (85 twas) were included in the study.There were 59 women and 16 men with a mean age of 59 years (26 to 86).The mean follow-up was 53 months (24 to 120).Clinical assessment involved recording pain on a visual analogue score, range of movement, grip strength, the quick disabilities of the arm, shoulder and hand (dash) and wrightington wrist scores.Any adverse effects were documented with particular emphasis on residual pain, limitation of movement, infection, dislocation, and the need for revision surgery.¿ ¿radiographic assessment was performed pre-operatively and at three, six and 12 months post-operatively, and annually thereafter.Arthroplasties were assessed for distal row intercarpal fusion and loosening.Radiolucent zones around the components were documented according to a system developed at our institution.¿ results: ¿the mean worst pain was 8.1 (3 to 10) pre-operatively and 5.4 (0 to 10) at latest follow-up (p < 0.001).Movements were preserved with mean dorsiflexion of 29 grades (0 grades to 70 grades) and palmar flexion of 21grades (0grades to 50grades).The mean grip strength was 4.8 kg (1.7 to 11.5) pre-operatively and 10 kg (0 to 28) at final follow-up (p < 0.001).The mean quickdash and wrightington wrist scores improved from 61 (16 to 91) to 46 (0 to 89) and 7.9 (1.8 to 10) to 5.7 (0 to 7.8) (p < 0.001).A total of six patients (7%) had major complications; three required revision arthroplasty and three an arthrodesis.The kaplan-meier probability of survival using removal of the components as the endpoint was 91% at 7.8 years (95% confidence interval 84 to 91).¿ conclusion: ¿the universal-2 twa is recommended for use in patients with rheumatoid arthritis.¿ this report is for the ¿adverse events¿: six revisions, three to a further twa and three to an arthrodesis.Persistent pain, nine patients (nine twas).Ulnar sided pain, five patients (five twas).Joint stiffness- wrist joint was deemed to be stiff if the patient failed to achieve a functional range of movement (combined dorsal and palmar flexion of < 15°).A total of nine twas (10.5%) fell into this category.Superficial wound infection, two patients (2.5%) - pseudomonas aeruginosa was isolated in one; this responded to antibiotics and settled within four weeks.Unfortunately, this patient was left with a stiff wrist.The second patient¿s infection was due to staphylococcus aureus and was again managed by a course of antibiotics.This settled completely and the patient had a satisfactory outcome.Doi:10.1302/0301-620x.98b12.

Event Description

N/a.

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM
• Type of Device: UNI2 TOTAL WRIST IMPLANT SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13455972
• MDR Text Key: 289273421
• Report Number: 1651501-2022-00002
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K030037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-UNI2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1