MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS RADIAL IMPLANT X-SMALL RIGHT; UNI2 TOTAL WRIST IMPLANT SYSTEM

Catalog Number 263100RT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

2 of 2 reports - other mfg report number: 1651501-2018-00029.It was reported by the patient that a freedom wrist implant had caused massive metallosis , failure of the poly, as well as prominent position of the components.The implant had caused ruptured tendons and lost of function of the patient's primary right hand.Removal and fusion using bone graft will be done to correct the deformed results.Additional information received on october 2nd, 2018: currently the patient have been in a hard cast since (b)(6), and on (b)(6) the doctor will determine at which time he'll probably remove the cast for a soft cast.The patient had undergone a fusion using cadaver bone.Additional information from medwatch report # mw5079719 was received: implant date: (b)(6) 2008.Explant date: (b)(6) 2018.Concomitant medical: hip replacement, gabapentin, levoyal, enbrolitianmizene, meloxicam, iron, black cohosh, vit.D, aspirin.

Manufacturer Narrative

Additional information received: the patient mentioned that "up until 2016, she was a buyer and had no issues with typing, writing, filing, etc.However, after that time, her fingers are stiff, no grasp, and difficult bending fingers with the right hand.The left hand has no problems¿.She stated she wore a soft cast from (b)(6) 2018(date of surgery) until (b)(6) 2018.She stated she has ¿double knuckles, no pain or swelling.

Manufacturer Narrative

Operative notes received on october 2018 (summary of operative notes): on (b)(6) 2008 the patient underwent a right wrist total wrist arthroplasty with use of fluoroscopy and application of short-arm splint due to right wrist rheumatoid arthritis.The procedure was well tolerated and the patient was transported to the recovery area in stable condition.On (b)(6) 2009, a revision surgery was done due to a right wrist contracture.The postoperative diagnosis was right wrist arthritis with contracture plus partial rupture extensor tendons of ring and small finger.The procedures were: right wrist revision total wrist arthroplasty.Reconstruction of extensor capsule and retinaculum.Tendon transfer of extensor digitorum communis mid-finger to extensor digitorum communis, ring and small.Application of short-arm splint and fluoroscopy.On (b)(6) 2018 the patient went to another surgeon and reported that the total wrist arthroplasty caused deformity in her fingers on the right as well as poor function of the right hand with very stiff digits.The surgeon notes state " she had some mp joint involvement with index and long subluxation; stiff swan-neck deformities in all the digits with preservation of the pip joint spaces.She also had swelling over the volar radial distal forearm.Mri showed massive fluid collection along the margin of the flexor tendons extending from the level of the distal radius into the carpal tunnel spanning 9cm in length." during surgery, the surgeon "came down on very dark black colored tissue that could be seen through the thin antebrachial fascia, what was apparent was that this was massive metallosis throughout the entire carpal tunnel and distal forearm.There were also numerous ruptured flexor tendons.There were a few broken pieces of poly that were removed.Surgeon states that the patient will need removal of her failed total wrist arthroplasty and conversion to a wrist fusion.The surgery was completed with no complications." on (b)(6) 2018 the patient had a follow up appointment with the surgeon and she reports some occasional pain in the right wrist and numbness in the thumb tip.During this visit the surgeon reports limited extension and wrist flexion with no obvious swelling in the volar wrist.The patient cannot actively extend the mp joints.During this visit, the hardware removal was scheduled.On (b)(6) 2018 the hardware removal was done.The procedure was a wrist scaphotrapeziotrapezoidal fusion.The surgical findings were: dislocated total wrist arthroplasty with significant metallosis of capsule.Components not frankly loose.The patient was transported to the recovery unit in stable condition with no apparent complications.

Manufacturer Narrative

The products were returned and underwent failure analysis.Failure analysis showed that the uhmpe articulating insert barrel bore and trunnion snap attachment appeared to have been damaged and disassociated.The uhmwpe insert was probably dislocated, which allowed metal to metal contact between the radius component and the carpal plate.The metal to metal contact preferentially wore away the titanium carpal plate relative to the cocr alloy radial component.Wear debris, uhmwpe and metallic particulate became entrained in the joint space on periprosthetic tissue.The reported complaint was confirmed.Based on the information to date, damage to the components, metallosis and soft tissue damage are consistent with device disassociation and dislocation.

• Brand Name: RADIAL IMPLANT X-SMALL RIGHT
• Type of Device: UNI2 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 ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8005948
• MDR Text Key: 125025766
• Report Number: 1651501-2018-00058
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K032686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 263100RT
• Device Lot Number: 077132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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