MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number UNKNOWN

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

Patient Problem Loss of Range of Motion (2032)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).Badge, r., kailash, k., dickson, d.R., mahalingam, s., raza, a., birch, a.,.& trail, i.A.(2016).Medium-term outcomes of the universal-2 total wrist arthroplasty in patients with rheumatoid arthritis.The bone & joint journal, 98(12), 1642-1647.Doi: 10.1302/0301-620x.98b12.37121.

Event Description

It was reported that, on literature review "medium-term outcomes of the universal-2 total wrist arthroplasty in patients with rheumatoid arthritis", 2 patients who initially underwent primary twa with a universal 2 twa implant to treat rheumatoid arthritis experienced postoperative loss of range of motion (combined dorsal and palmar flexion of < 15 degrees) and required a capsular release under general anesthesia.During this procedure, both volar and dorsal releases were performed through separate incisions, and the capsule was released from the radius.These patients required later a revision arthroplasty to resolve lack of movement at the joint.The outcome of both patients is unknown at this time.No further information is available.

Manufacturer Narrative

H10: this complaint was originally created in the integra lifesciences complaint management system.This complaint is being migrated into smartsolve as complaint handling for this product has transferred from integra to smith+nephew.As such, some details in the complaint record may represent legacy integra complaint handling processes.No parts associated with this complaint have been returned to austin for evaluation, so the failure could not be confirmed.According to risk documentation for the uni2 system, potential causes for the adverse events alleged by this complaint include inadequate design, inadequate or incorrect surgical technique, and inappropriate patient selection.If the part is later returned, this investigation may be reopened and updated.As the parts were not returned, a definitive root cause could not be determined.According to risk documentation for the uni2 system, potential causes for the adverse events alleged by this complaint include inadequate design, inadequate or incorrect surgical technique, and inappropriate patient selection.If the part is later returned, this investigation may be reopened and updated.Internal complaint reference number: (b)(4).

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• 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: 14477583
• MDR Text Key: 292513595
• Report Number: 3002788818-2022-00020
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other