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U.S. Department of Health and Human Services

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

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ASCENSION ORTHOPEDICS UNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM UNI2 TOTAL WRIST IMPLANT SYSTEM Back to Search Results
Catalog Number XXX-UNI2
Device Problems Material Integrity Problem (2978); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information. Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue. Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not. Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr). The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from (b)(4) to (b)(4). Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps. Capa pr (b)(4) and nc (b)(4) have been opened by integra to further investigate the nonconformance and develop a corrective action plan. The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda. Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020. Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
 
Event Description
American association for hand surgery(2018) published: "revision total wrist arthroplasty due to polyethylene wear, metallosis-induced carpal tunnel syndrome, distal ulnar impingement, and fourth carpometacarpal joint pain: case report and pitfalls to avoid". The purpose of this study is to illustrate an array of preventable complications which are addressed through operative technique in revision setting. Methods: preventable complications associated with twa are individually highlighted. In addition, we compare and contrast our approach and surgical technique to current reported literature. Overall, we provide education and guidance to avoid possible twa pitfalls. The patient was a (b)(4) man who presented with complaints of progressive right wrist pain, paresthesia, swelling, and dysfunction starting within a month of revision twa. Case presentation: the patient was a (b)(4) man who presented with chronic pain at the fourth carpometacarpal joint (cmcj) and distal radioulnar joint with paresthesia in the median nerve distribution. Surgery was undertaken to address the following complications secondary to a previous twa (size 2 carpal component of the second -generation universal twa - integra): impingement of the native distal ulna on the prosthesis, carpal tunnel due to metallosis and polyethylene synovitis, loose carpal component, and prominent screw at the fourth cmcj. Surgical correction included open carpal tunnel release with extensive flexor tenosynovectomy, distal ulna resection and implant arthroplasty with shortening, revision of carpal component with bone grafting, and shortening of the ulnar screw to avoid crossing the fourth cmcj. Previous twa was replaced with a size 2 third-generation universal twa - integra). Within 6 months of the procedure, the patient reported resolution of neuropathic symptoms and pain-free motion of the wrist. Results: complication rates of twa are varied and higher than those presented in the wrist arthrodesis literature, with a considerable rate of radiological loosening and osteolysis. 12 complication rates have been reported up to 32%,13 but have been decreasing with improved knowledge, experience, surgical technique, and implant design. 10 boeckstyns reports in a systematic review the survival rates to vary between wrist prostheses, but most studies quote 90% to 100% at 5 years. 10 as with all forms of arthroplasty, complications can still occur despite vigilant perioperative measures. Conclusions: a high index of suspicion should be maintained for metallosis with unexplained joint pain, swelling, and signs of compressive median neuropathy following twa. Crossing the fourth cmcj with the ulnar carpal component screw will cause pain due to joint mobility. Aseptic loosening should be suspected with postoperative wrist pain when the fourth cmcj was violated and not fused. In addition, patients undergoing twa must be evaluated for druj pain, which may indicate whether distal ulna resection or replacement is required. Overall, with judicious patient selection, preoperative planning, surgical technique, and complication awareness, twa is an effective procedure to alleviate pain secondary to arthritis while optimizing wrist function, stability, and durability. Doi: (b)(4).
 
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Brand NameUNIVERSAL2 TOTAL WRIST IMPLANT SYSTEM
Type of DeviceUNI2 TOTAL WRIST IMPLANT SYSTEM
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX 78754
Manufacturer (Section G)
ASCENSION ORTHOPEDICS
8700 cameron road #100
austin TX 78754
Manufacturer Contact
vivian nelson
1000 campus drive
princeton, NJ 08536
6099362319
MDR Report Key10277014
MDR Text Key205576524
Report Number1651501-2019-00051
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
PMA/PMN Number
K030037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-UNI2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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